Systems and methods for a continuous monitoring of analyte values

ABSTRACT

Systems and methods for a continuous monitoring of analyte values received from an analyte sensor system are provided. One method for a wireless data communication between an analyte sensor system and a mobile device involves storing identification information associated with a transceiver of the analyte sensor system, the identification information entered by a user of the mobile device via a custom application running on the mobile device; causing the custom application to enter a background mode; searching for advertisement signals; receiving an advertisement signal from the transceiver; authenticating the transceiver based on the identification information; prompting the user to bring the custom application to a foreground mode; causing the custom application to request a confirmation from the user that a data connection with the transceiver is desired; receiving the confirmation from the user; and completing the data connection with the transceiver.

INCORPORATION BY REFERENCE TO RELATED APPLICATION

Any and all priority claims identified in the Application Data Sheet, orany correction thereto, are hereby incorporated by reference under 37CFR 1.57. This application is a continuation of U.S. application Ser.No. 16/420,045, filed May 22, 2019, which is a continuation of U.S.application Ser. No. 15/862,102, filed Jan. 4, 2018, now U.S. Pat. No.10,335,065, which is a continuation of U.S. application Ser. No.14/533,943, filed Nov. 5, 2014, now U.S. Pat. No. 9,974,469, whichclaims the benefit of U.S. Provisional Application No. 61/901,358 filedNov. 7, 2013. The aforementioned application is incorporated byreference herein in its entirety, and is hereby expressly made a part ofthis specification.

FIELD

Systems and methods for a continuous monitoring of analyte valuesreceived from an analyte sensor system are provided.

BACKGROUND

Diabetes mellitus is a disorder in which the pancreas cannot createsufficient insulin (Type I or insulin dependent) and/or in which insulinis not effective (Type 2 or non-insulin dependent). In the diabeticstate, the victim suffers from high blood sugar, which causes an arrayof physiological derangements (kidney failure, skin ulcers, or bleedinginto the vitreous of the eye) associated with the deterioration of smallblood vessels. A hypoglycemic reaction (low blood sugar) may be inducedby an inadvertent overdose of insulin, or after a normal dose of insulinor glucose-lowering agent accompanied by extraordinary exercise orinsufficient food intake.

Conventionally, a diabetic person carries a self-monitoring bloodglucose (SMBG) monitor, which typically requires uncomfortable fingerpricking methods. Due to the lack of comfort and convenience, a diabeticwill normally only measure his or her glucose level two to four timesper day. Unfortunately, these time intervals are spread so far apartthat the diabetic will likely find out too late, sometimes incurringdangerous side effects, of a hyperglycemic or hypoglycemic condition. Infact, it is not only unlikely that a diabetic will take a timely SMBGvalue, but additionally the diabetic will not know if his blood glucosevalue is going up (higher) or down (lower) based on conventionalmethods.

Consequently, a variety of non-invasive, transdermal (e.g.,transcutaneous) and/or implantable electrochemical sensors are beingdeveloped for continuously detecting and/or quantifying blood glucosevalues. These devices generally transmit raw or minimally processed datafor subsequent analysis at a remote device, which can include a display.

SUMMARY

Details of one or more implementations of the subject matter describedin this specification are set forth in the accompanying drawings and thedescription below. Other features, aspects, and advantages will becomeapparent from the description, the drawings, and the claims. Note thatthe relative dimensions of the following figures may not be drawn toscale.

In a first aspect, a method for a wireless data communication between ananalyte sensor system and a mobile device capable of wirelesslyreceiving analyte values from the analyte sensor system is provided. Themethod can comprise storing identification information associated with atransceiver of the analyte sensor system, the identification informationentered by a user of the mobile device via a custom application runningon the mobile device; causing the custom application to enter abackground mode; searching for advertisement signals; receiving anadvertisement signal from the transceiver; authenticating thetransceiver based on the identification information; prompting the userto bring the custom application to a foreground mode; causing the customapplication to request a confirmation from the user that a dataconnection with the transceiver is desired; receiving the confirmationfrom the user; and completing the data connection with the transceiver.

In certain implementations of the first aspect, which is generallyapplicable, particularly with any other implementation of the firstaspect, the method can further comprise receiving an analyte value fromthe transceiver; terminating the data connection with the transceiver;entering an inactive mode; exiting the inactive mode after apredetermined time; and searching for advertisement signal from thetransceiver.

In certain implementations of the first aspect, which is generallyapplicable, particularly with any other implementation of the firstaspect, the authenticating step can comprise requesting a challengevalue from the transceiver; receiving the challenge value from thetransceiver; generating a hash value from the challenge value and theidentification information; transmitting the hash value to thetransceiver; and receiving a confirmation indicating a successfulauthentication from the transceiver.

In certain implementations of the first aspect, which is generallyapplicable, particularly with any other implementation of the firstaspect, the method can further comprise determining that an excessivememory is being used by the custom application; causing the customapplication to enter a suspended state; determining a next scheduledtime at which the custom application is expected to search foradvertisement signals from the transceiver; and causing the customapplication to exit the suspended state prior to the next scheduledtime.

In a second aspect is provided a mobile device configured for a wirelessdata communication with an analyte sensor system, comprising: a userinterface; a radio unit for transmitting and receiving wireless signals;a memory for storing identification information associated with one ormore transceivers and a custom application configured to interact with auser of the mobile device via the user interface; and a processoroperatively coupled to the user interface, the radio unit, and thememory and configured to: cause the custom application to enter abackground mode, cause the radio unit to search for advertisementsignals, perform an authentication procedure with a transceiver of theanalyte sensor system based on user-entered identification informationassociated with the transceiver if an advertisement signal is receivedfrom the transceiver, issue a first notification to the user to bringthe custom application into a foreground mode, cause the customapplication to issue a second notification requesting the user for aconfirmation that a data connection with the transceiver is desired, andcomplete the data connection with the transceiver if the confirmation isreceived.

In certain implementations of the second aspect, which is generallyapplicable, particularly with any other implementation of the secondaspect, the analyte sensor system can be a continuous glucose sensorsystem.

In certain implementations of the second aspect, which is generallyapplicable, particularly with any other implementation of the secondaspect, the user interface can comprise a voice user interface.

In certain implementations of the second aspect, which is generallyapplicable, particularly with any other implementation of the secondaspect, the user interface can comprise a touch screen display.

In certain implementations of the second aspect, which is generallyapplicable, particularly with any other implementation of the secondaspect, the first notification can be a pop-up menu displayed on thetouch screen display.

In certain implementations of the second aspect, which is generallyapplicable, particularly with any other implementation of the secondaspect, the wireless data communication can employ a communicationprotocol designed for a short distance and low-power wirelesscommunication.

In certain implementations of the second aspect, which is generallyapplicable, particularly with any other implementation of the secondaspect, the processor can be further configured to determine that anexcessive memory space has been used by the custom application; causethe custom application to enter a suspended state, cause the customapplication to exit the suspended state prior to a scheduled time atwhich the mobile device is expected to search for a next advertisementsignal from the transceiver, and cause the custom application to searchfor the next advertisement signal in a background mode.

In certain implementations of the second aspect, which is generallyapplicable, particularly with any other implementation of the secondaspect, the processor can be further configured to determine that anexcessive memory is being used by the custom application; cause thecustom application to enter a suspended state, determine a nextscheduled time at which the transceiver is expected to begintransmitting a series of advertisement signals, cause the customapplication to exit the suspended state prior to the next scheduledtime, and cause the radio unit to search for the advertisement signals.

In certain implementations of the second aspect, which is generallyapplicable, particularly with any other implementation of the secondaspect, the processor can be further configured to determine that anexcessive memory is being used by the custom application, cause thecustom application to enter a suspended state, determine a nextscheduled time at which the transceiver is expected to begintransmitting a series of advertisement signals, and cause the radio tosearch for the advertisement signals at the next scheduled time whilethe custom application is still in the suspended state.

In a third aspect is provided a method for a wireless data communicationbetween an analyte sensor system and a mobile device capable ofwirelessly receiving analyte values from the analyte sensor system, themethod comprising: transmitting a first series of advertisement signalsbeginning at a first time; receiving a data connection request from amobile device at a second time; establishing a data connection with themobile device; transmitting a connection interval indicative of adifference between the second time and the first time to the mobiledevice; transmitting an analyte value; terminating the data connectionwith the mobile device; and causing a transceiver of the analyte sensorsystem to enter a sleep state.

In certain implementations of the third aspect, which is generallyapplicable, particularly with any other implementation of the thirdaspect, the method can further comprise causing the transceiver to exitthe sleep mode after a predetermined time; and transmitting a secondseries of advertisement signals.

In certain implementations of the third aspect, which is generallyapplicable, particularly with any other implementation of the thirdaspect, the predetermine time can be between about 200 and 400 seconds.

In certain implementations of the third aspect, which is generallyapplicable, particularly with any other implementation of the thirdaspect, the analyte value can be based on an analyte measurement takenwhile the transceiver was in a previous sleep mode.

In a fourth aspect is provided a method for a wireless datacommunication between an analyte sensor system and a mobile devicecapable of wirelessly receiving analyte values from the analyte sensorsystem, the method comprising: searching for advertisement signals;receiving an advertisement signal from a transceiver of the analytesensor system; transmitting a data connection request to thetransceiver; establishing a data connection with the transceiver if thedata connection request is granted; receiving a connection intervalindicative of a difference between a first time at which the transceiverstarted to transmit a series of advertisement signals and a second timeat which the transceiver received the data connection request from themobile device; receiving an analyte value from the transceiver;terminating the data connection with the transceiver, thereby causingthe transceiver to enter a sleep mode; entering an inactive mode duringwhich the mobile device does not communicate with the transceiver;calculating an exit time at which the mobile device is to exit theinactive mode based at least partly on the connection interval; exitingthe inactive mode at the exit time; and search for advertisement signalsafter exiting the inactive mode.

In certain implementations of the fourth aspect, which is generallyapplicable, particularly with any other implementation of the fourthaspect, the analyte value can be based on an analyte measurement takenwhile the transceiver was in a previous sleep mode.

In certain implementations of the fourth aspect, which is generallyapplicable, particularly with any other implementation of the fourthaspect, the exit time can be given by current time+update interval−theconnection interval−notification delay−safeguard, the update intervalcan be a time duration between two consecutive wireless communicationsessions between the transceiver and the mobile device.

In certain implementations of the fourth aspect, which is generallyapplicable, particularly with any other implementation of the fourthaspect, the update interval can be between about 200 and 400 seconds.

In certain implementations of the fourth aspect, which is generallyapplicable, particularly with any other implementation of the fourthaspect, the connection interval can be between about 90 and 300milliseconds.

In certain implementations of the fourth aspect, which is generallyapplicable, particularly with any other implementation of the fourthaspect, the notification delay can be between about 100 and 300milliseconds and the safeguard is typically between about 300 and 700milliseconds.

In a fifth aspect is provided an analyte sensor system configured for awireless data communication with a mobile device comprising: an analytesensor; a transceiver configured to transmit and receive wirelesssignals; and a processor operatively coupled to the analyte sensor andthe transceiver and configured to: cause the transceiver to transmit aseries of advertisement signals, receive a data connection request froma mobile device, cause the transceiver to establish a data connectionwith a radio unit of the mobile device, cause the transceiver totransmit a connection interval for use by the mobile device forcalculating an exit time at which the mobile device is to exit aninactive mode and start to search for an advertisement signal, cause thetransceiver to transmit an analyte value, cause the transceiver toterminate the data connection, and cause the transceiver to enter asleep mode.

In certain implementations of the fifth aspect, which is generallyapplicable, particularly with any other implementation of the fifthaspect, the processor can be further configured to cause the transceiverto exit the sleep mode after a predetermined time period; and cause thetransceiver to transmit a second series of advertisement signals.

In certain implementations of the fifth aspect, which is generallyapplicable, particularly with any other implementation of the fifthaspect, the connection interval can be a function of a differencebetween a first time at which the transceiver began to transmit a seriesof advertisement signals and a second time at which the transceiverreceived the data connection request from the mobile device.

In certain implementations of the fifth aspect, which is generallyapplicable, particularly with any other implementation of the fifthaspect, the analyte sensor can be a continuous glucose sensor.

In a sixth aspect is provided a mobile device configured for a wirelessdata communication with an analyte sensor system, the mobile devicecomprising: a memory for storing a custom application; a radio unit fortransmitting and receiving wireless signals; and a processor operativelycoupled to the memory and the radio unit and configured to: cause theradio unit to search for advertisement signals, receive an advertisementsignal from a transceiver associated with the analyte sensor system,cause the radio unit to transmit a data connection request to thetransceiver, receive a grant of the data connection request from thetransceiver, cause the radio unit to establish a data connection withthe transceiver, receive a connection interval indicative of an amountof time elapsed between a beginning of transmission of a series ofadvertisement signals by the transceiver and a reception of a dataconnection request by the transceiver, cause the radio unit to terminatethe data connection with the transceiver, cause the radio unit to enteran inactive mode during which the radio unit does not communicate withthe transceiver, calculate an exit time based at least partly on theconnection interval, cause the radio unit to exit from the inactive modeat the exit time, and cause the radio unit to search for advertisementsignals after exiting the inactive mode.

In certain implementations of the sixth aspect, which is generallyapplicable, particularly with any other implementation of the sixthaspect, the analyte sensor system can be a continuous glucose sensorsystem.

In certain implementations of the sixth aspect, which is generallyapplicable, particularly with any other implementation of the sixthaspect, the mobile device can be a mobile phone.

In certain implementations of the sixth aspect, which is generallyapplicable, particularly with any other implementation of the sixthaspect, the exit time can be given by current time+update interval−theconnection time−notification delay−safeguard, the update interval can bea time duration between two consecutive wireless communication sessionsbetween the transceiver and the mobile device.

In a seventh aspect is provided a method for a wireless datacommunication between an analyte sensor system and a plurality ofdisplay devices capable of displaying analyte values wirelessly receivedfrom the analyte sensor system, the method comprising: transmitting afirst series of advertisement signals; receiving a first data connectionrequest from a first display device; determining whether the firstdisplay device is identified in a list for containing a single alloweddisplay device; and rejecting the first data connection request from thefirst display device at a radio hardware level if the first displaydevice is not identified in the list.

In certain implementations of the seventh aspect, which is generallyapplicable, particularly with any other implementation of the seventhaspect, the method further comprises granting the first data connectionfrom the first display device at the radio hardware level if the firstdisplay device is identified in the list.

In certain implementations of the seventh aspect, which is generallyapplicable, particularly with any other implementation of the seventhaspect, the method further comprises establishing a first dataconnection with the first display device and transmitting an analytevalue to the first display device.

In certain implementations of the seventh aspect, which is generallyapplicable, particularly with any other implementation of the seventhaspect, the analyte value can be indicative a blood glucose value.

In certain implementations of the seventh aspect, which is generallyapplicable, particularly with any other implementation of the seventhaspect, the information identifying one or more display devices thathave been paired with the transceiver can also be stored in the list.

In certain implementations of the seventh aspect, which is generallyapplicable, particularly with any other implementation of the seventhaspect, the information identifying one or more display devices thathave been paired with the transceiver can be stored in a different list.

In certain implementations of the seventh aspect, which is generallyapplicable, particularly with any other implementation of the seventhaspect, the method can further comprise continuing to accept dataconnection requests from one or more display devices when no otherdisplay device has been paired with the analyte sensor system.

In certain implementations of the seventh aspect, which is generallyapplicable, particularly with any other implementation of the seventhaspect, the method can further comprise clearing the list if apredetermined condition is met.

In certain implementations of the seventh aspect, which is generallyapplicable, particularly with any other implementation of the seventhaspect, the predetermined condition can be a failure to receive a dataconnection request from a listed display device identified in the listwithin a predetermined number of communication sessions.

In certain implementations of the seventh aspect, which is generallyapplicable, particularly with any other implementation of the seventhaspect, the predetermined condition can be reception of a clearancesignal from a listed display device identified in the list indicatingthat the listed display device is to be cleared from the list.

In certain implementations of the seventh aspect, which is generallyapplicable, particularly with any other implementation of the seventhaspect, the method can further comprise receiving a second dataconnection request from a second display device; determine that the listhas been cleared; grant the second data connection request; and writedata identifying the second display device in the list.

In an eighth aspect is provided an analyte sensor system configured fora wireless data communication with a plurality of display devicescapable of displaying analyte values wirelessly received from theanalyte sensor system, the analyte sensor system comprising: an analytesensor; a memory for storing a list identifying a single allowed displaydevice; a transceiver configured to transmit and receive wirelesssignals; and a processor operatively coupled to the analyte sensor, thememory, and the transceiver and configured to: cause the transceiver totransmit a first series of advertisement signals, receive a first dataconnection request from a first display device, determine that the firstdisplay device is not identified in the list, and reject the dataconnection request from the first display device at a radio hardwarelevel.

In certain implementations of the eighth aspect, which is generallyapplicable, particularly with any other implementation of the eighthaspect, the analyte sensor can be a continuous glucose sensor.

In certain implementations of the eighth aspect, which is generallyapplicable, particularly with any other implementation of the eighthaspect, one of the plurality of display devices can be a custom analytemonitoring device and another one of the plurality of display devices isa mobile device.

In certain implementations of the eighth aspect, which is generallyapplicable, particularly with any other implementation of the eighthaspect, the wireless data communication can employ a short-distance andlow-power wireless communication protocol.

In certain implementations of the eighth aspect, which is generallyapplicable, particularly with any other implementation of the eighthaspect, the processor can be a link layer (LL) controller.

In certain implementations of the eighth aspect, which is generallyapplicable, particularly with any other implementation of the eighthaspect, the list can be a white list maintained in the LL controller.

In certain implementations of the eighth aspect, which is generallyapplicable, particularly with any other implementation of the eighthaspect, the processor can be further configured to cause the transceiverto continue transmitting one or more advertisement signals afterrejecting the first data connection request, receive a data connectionrequest from a second display device, and establish a data connectionwith the second display device if the second display device isidentified in the list.

In certain implementations of the eighth aspect, which is generallyapplicable, particularly with any other implementation of the eighthaspect, the processor can be further configured to engage in datacommunication with the second display device after establishing the dataconnection, terminate the data connection after completing the datacommunication, and cause the transceiver to enter a sleep mode.

In certain implementations of the eighth aspect, which is generallyapplicable, particularly with any other implementation of the eighthaspect, the processor can be further configured to clear the list if apredetermined condition is met.

In certain implementations of the eighth aspect, which is generallyapplicable, particularly with any other implementation of the eighthaspect, the predetermined condition can include a failure to receive adata connection request from a listed display device identified in thelist within a predetermined number of communication sessions.

In certain implementations of the eighth aspect, which is generallyapplicable, particularly with any other implementation of the eighthaspect, the predetermined condition includes a reception of a clearancesignal from a listed display device can be identified in the listindicating that the listed display device is to be cleared from thelist.

In certain implementations of the eighth aspect, which is generallyapplicable, particularly with any other implementation of the eighthaspect, the processor can be further configured to receive a second dataconnection request from a second display device, determine that the listhas been cleared, cause the transceiver to grant the second dataconnection request, and write data identifying the second display devicein the list. In a ninth aspect is provided a method for a wireless datacommunication between an analyte sensor system and a plurality ofdisplay devices capable of displaying analyte values wirelessly receivedfrom the analyte sensor system, the method comprising: transmitting afirst series of advertisement signals; receiving a first data connectionrequest from a first display device; determining that the first displaydevice is identified in a first list containing one or more alloweddisplay devices; establishing a first data connection with the firstdisplay device; transmitting a first signal to the first display deviceindicating that a different display device is identified in a secondlist for containing a single currently active display device; receivinga second signal from the first display device indicating that the firstdisplay device is a newly selected active display device; changing thesecond list to indicate that the first display device is the currentlyactive display device; and terminating the first data connection withthe first display device.

In certain implementations of the ninth aspect, which is generallyapplicable, particularly with any other implementation of the ninthaspect, the method can further comprise determining that the firstdisplay device is not identified in the second list.

In certain implementations of the ninth aspect, which is generallyapplicable, particularly with any other implementation of the ninthaspect, the method can further comprise receiving a request from thefirst display device to transmit the first signal.

In certain implementations of the ninth aspect, which is generallyapplicable, particularly with any other implementation of the ninthaspect, the method can further comprise reading from the second listfirst data identifying the different display device as the currentlyactive display device; and including the first data in the first signaltransmitted to the first display device.

In certain implementations of the ninth aspect, which is generallyapplicable, particularly with any other implementation of the ninthaspect, the second signal can comprise a request to write to the secondlist second data identifying the first display device as the currentlyactive display device.

In certain implementations of the ninth aspect, which is generallyapplicable, particularly with any other implementation of the ninthaspect, the method can be further comprised transmitting a second seriesof advertisement signals; receiving a second data connection requestfrom the first display device; establishing a second data connectionwith the first display device; determining that the first display deviceis identified in the second list; transmitting an analyte value to thefirst display device; and terminating the second data connection withthe first display device.

In certain implementations of the ninth aspect, which is generallyapplicable, particularly with any other implementation of the ninthaspect, the method can be further comprised transmitting a third seriesof advertisement signals; receiving a third data connection request froma second display device; establishing a third data connection with thesecond display device if it is determined that the second display deviceis identified in the first list; transmitting a third signal to thesecond display indicating that a different display device is identifiedin the second list; receiving a fourth signal from the second displaydevice, the fourth signal indicating that the third display device isnot a newly selected active display device; and terminating the thirddata connection with the second display device without changing thesecond list.

In a tenth aspect is provided an analyte sensor system configured for awireless data communication with a plurality of display devices capableof displaying analyte values from the analyte sensor module, the analytesensor system comprising: an analyte sensor; a transceiver configured totransmit and receive wireless signals; and a processor operativelycoupled to the analyte sensor, and the transceiver and configured to:cause the transceiver to transmit a first series of advertisementsignals, receive a first data connection request from a first displaydevice, determine that the first display device is identified in a firstlist containing one or more allowed display devices, establish a firstdata connection with the first display device, read from a second listfirst data identifying a different display device as a currently activedisplay device, transmit the first data to the first display device,receive a request to write to the second list second data identifyingthe first display device as a currently active display device, write thesecond data to the second list, and terminate the first data connectionwith the first display device.

In certain implementations of the tenth aspect, which is generallyapplicable, particularly with any other implementation of the tenthaspect, the analyte sensor can be a continuous glucose sensor.

In certain implementations of the tenth aspect, which is generallyapplicable, particularly with any other implementation of the tenthaspect, at least one of the first display device and the differentdisplay device can be a custom analyte monitoring device and the otherof the first display device and the different display device is a mobiledevice.

In certain implementations of the tenth aspect, which is generallyapplicable, particularly with any other implementation of the tenthaspect, the mobile device can be a mobile phone.

In certain implementations of the tenth aspect, which is generallyapplicable, particularly with any other implementation of the tenthaspect, the processor can be configured to reject a data connectionrequest from a display device not identified in the first list at aradio hardware level.

In certain implementations of the tenth aspect, which is generallyapplicable, particularly with any other implementation of the tenthaspect, the processor can comprise a link layer (LL) controller.

In certain implementations of the tenth aspect, which is generallyapplicable, particularly with any other implementation of the tenthaspect, the first list can be a white list maintained in the LLcontroller.

In certain implementations of the tenth aspect, which is generallyapplicable, particularly with any other implementation of the tenthaspect, the processor can be further configured to cause the transceiverto transmit a second series of advertisement signals, receive a seconddata connection request from the first display device, cause thetransceiver to establish a second data connection with the first displaydevice, determine that the first display device is identified in thesecond list, cause the transceiver to transmit an analyte value to thefirst display device, and cause the transceiver to terminate the seconddata connection with the first display device.

In certain implementations of the tenth aspect, which is generallyapplicable, particularly with any other implementation of the tenthaspect, the processor can be further configured to cause the transceiverto enter a sleep mode; and cause the transceiver to exit the sleep modeafter a predetermined time.

In certain implementations of the tenth aspect, which is generallyapplicable, particularly with any other implementation of the tenthaspect, the predetermined time can be between about 200 and 300 seconds.

In certain implementations of the tenth aspect, which is generallyapplicable, particularly with any other implementation of the tenthaspect, the processor can be further configured to take a measurement ofan output of the analyte sensor while the transceiver is in the sleepmode.

In certain implementations of the tenth aspect, which is generallyapplicable, particularly with any other implementation of the tenthaspect, processor can be further configured to cause the transceiver totransmit a third series of advertisement signals after exiting, receivea third data connection request from a second display device, cause thetransceiver to establish a third data connection with the second displaydevice if it is determined that the second display device is identifiedin the first list, cause the transceiver to transmit a third signal tothe second display indicating that a different display device isidentified in the second list, receive a fourth signal from the seconddisplay device, the fourth signal indicating that the third displaydevice is not a newly selected active display device, and cause thetransceiver to terminate the third data connection with the seconddisplay device without changing the second list.

In a eleventh aspect is provided a method for wireless datacommunication among an analyte sensor system, a passive device forreceiving data from the transceiver without establishing a dataconnection with the analyte sensor system, and an active display devicefor displaying analyte data from the analyte sensor system afterestablishing a data connection with the analyte sensor system, themethod comprising: the passive device receiving a first advertisementsignal from the analyte sensor system, the first advertisement signalincluding data to be used by the passive device; and the passive deviceextracting the data from the first advertisement signal.

In certain implementations of the eleventh aspect, which is generallyapplicable, particularly with any other implementation of the eleventhaspect, the data can be included in the first advertisement signalincludes an analyte value.

In certain implementations of the eleventh aspect, which is generallyapplicable, particularly with any other implementation of the eleventhaspect, the analyte value can be an encoded analyte value.

In certain implementations of the eleventh aspect, which is generallyapplicable, particularly with any other implementation of the eleventhaspect, the method can further comprise the active display devicereceiving a second advertisement signal from the transceiver; the activedisplay device establishing a data connection with the transceiver inresponse to the second advertisement signal; and the active displaydevice receiving an analyte value to be displayed on the active displaydevice.

In certain implementations of the eleventh aspect, which is generallyapplicable, particularly with any other implementation of the eleventhaspect, the second advertisement signal can be same as the firstadvertisement signal.

In certain implementations of the eleventh aspect, which is generallyapplicable, particularly with any other implementation of the eleventhaspect, the second advertisement signal can be different from the firstadvertisement signal.

In a twelfth aspect is provided a system for wireless data communicationcomprising: an analyte sensor system configured to transmit a series ofadvertisement signals; a passive device configured to: receive a firstadvertisement signal from the analyte sensor system, the firstadvertisement signal being one of the series of advertisement signalstransmitted by the analyte sensor system and including data to be usedby the passive device, and extract the data from the first advertisementsignal without establishing a data connection with the analyte sensorsystem; and an active display device configured to: receive a secondadvertisement signal from the analyte sensor system, the secondadvertisement signal being one of the series of advertisement signalstransmitted by the analyte sensor system, establish a data connectionwith the analyte sensor system in response to the second advertisementsignal, receive an analyte value from the analyte sensor system,terminate the data connection, and display the analyte value.

In certain implementations of the twelfth aspect, which is generallyapplicable, particularly with any other implementation of the twelfthaspect, the data to be used by the passive device can include an encodedanalyte value.

In certain implementations of the twelfth aspect, which is generallyapplicable, particularly with any other implementation of the twelfthaspect, the analyte sensor system can be a continuous glucose sensorsystem and the passive device is an insulin pump configured for insulinadministration.

In certain implementations of the twelfth aspect, which is generallyapplicable, particularly with any other implementation of the twelfthaspect, the data included in the first advertisement signal can beindicative of a glucose level and further wherein the insulin pump isconfigured to suspend the insulin administration if the glucose levelfalls below a threshold value.

Any of the features of aspects specified herein are applicable to allother aspects and embodiments identified herein. Moreover, any of thefeatures of an aspect is independently combinable, partly or wholly withother aspects described herein in any way, e.g., one, two, or three ormore aspects may be combinable in whole or in part. Further, any of thefeatures of an aspect may be made optional to other aspects. Any aspectof a method can be performed by a system or apparatus of another aspect,and any aspect or of a system can be configured to perform a method ofanother aspect.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram illustrating certain embodiments of a continuousanalyte sensor system according certain aspects of the presentdisclosure.

FIG. 2A is a perspective view of an exemplary sensor system that canembody the analyte sensor system according to certain aspects of thepresent disclosure.

FIG. 2B is a side view of an exemplary sensor system that can embody theanalyte sensor system according to certain aspects of the presentdisclosure.

FIG. 3 is an exemplary block diagram illustrating various elements ofcertain embodiments of a continuous analyte monitoring system comprisingan analyte sensor system and a plurality of display devices according tocertain aspects of the present disclosure.

FIG. 4 is a flow diagram illustrating an exemplary wireless datacommunication procedure between an analyte sensor system and a displaydevice capable of wireless receiving analyte values from the analytesensor system according to certain aspects of the present disclosure.

FIG. 5 is a flowchart illustrating an exemplary process for facilitatingan initial setup procedure between an analyte sensor system and a mobiledevice according to certain aspects of the present disclosure.

FIG. 6 is a flowchart illustrating an exemplary process for facilitatinga wireless data communication between an analyte sensor system and amobile device capable of wirelessly receiving analyte values from theanalyte sensor system by causing a custom application to exit asuspended state prior to a next scheduled data communication eventaccording certain aspects of the present disclosure.

FIG. 7 is a flowchart illustrating an exemplary process for minimizingthe number of advertisement signals that the transceiver of the analytesensor system transmits before establishing a data connection with thedisplay device according certain aspects of the present disclosure.

FIGS. 8A and 8B represent a flow diagram illustrating an exemplarysystem and method for rejecting a data connection request from a displaydevice not identified in a list containing a single allowed displaydevice according to certain aspects of the present disclosure.

FIGS. 9A and 9B represent a flow diagram illustrating an exemplaryprocedure for facilitating a switch between two display devices thatmakes use of two separate lists according certain aspects of the presentdisclosure.

FIG. 10 is a diagram illustrating a wireless data communication systemincluding an analyte sensor system, an active display device, and apassive display device according to certain aspects of the presentdisclosure.

FIG. 11 is a flowchart illustrating an exemplary process for allowing apassive device to receive desired data from an analyte sensor systemwithout being paired or connected to the analyte sensor system accordingto certain aspects of the present disclosure.

DETAILED DESCRIPTION

The following description and examples illustrate some exemplaryembodiments of the disclosed invention in detail. Those of skill in theart will recognize that there are numerous variations and modificationsof this invention that are encompassed by its scope. Accordingly, thedescription of a certain exemplary embodiment should not be deemed tolimit the scope of the present invention.

Overview

In some embodiments, a system is provided for continuous measurement ofan analyte in a host that includes: a continuous analyte sensorconfigured to continuously measure a concentration of the analyte in thehost and a sensor electronics module physically connected to thecontinuous analyte sensor during sensor use. In certain embodiments, thesensor electronics module includes electronics configured to process adata stream associated with an analyte concentration measured by thecontinuous analyte sensor in order to generate sensor information thatincludes raw sensor data, transformed sensor data, and/or any othersensor data, for example. The sensor electronics module may further beconfigured to generate sensor information that is customized forrespective display devices, such that different display devices mayreceive different sensor information.

The term “analyte” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to a substance or chemicalconstituent in a biological fluid (for example, blood, interstitialfluid, cerebral spinal fluid, lymph fluid or urine) that can beanalyzed. Analytes can include naturally occurring substances,artificial substances, metabolites, and/or reaction products. In someembodiments, the analyte for measurement by the sensor heads, devices,and methods is analyte. However, other analytes are contemplated aswell, including but not limited to acarboxyprothrombin; acylcarnitine;adenine phosphoribosyl transferase; adenosine deaminase; albumin;alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle),histidine/urocanic acid, homocysteine, phenylalanine/tyrosine,tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers;arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactiveprotein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholicacid; chloroquine; cholesterol; cholinesterase; conjugated 1-βhydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MMisoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine;dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcoholdehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Beckermuscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A,hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F,D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1,Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax,sexual differentiation, 21-deoxycortisol); desbutylhalofantrine;dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocytearginase; erythrocyte protoporphyrin; esterase D; fattyacids/acylglycines; free β-human chorionic gonadotropin; freeerythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine(FT3); fumarylacetoacetase; galactose/gal-1-phosphate;galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphatedehydrogenase; glutathione; glutathione perioxidase; glycocholic acid;glycosylated hemoglobin; halofantrine; hemoglobin variants;hexosaminidase A; human erythrocyte carbonic anhydrase I;17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase;immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, β);lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin;phytanic/pristanic acid; progesterone; prolactin; prolidase; purinenucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3);selenium; serum pancreatic lipase; sissomicin; somatomedin C; specificantibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody,arbovirus, Aujeszky's disease virus, dengue virus, Dracunculusmedinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus,Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpesvirus, HIV-1, IgE (atopic disease), influenza virus, Leishmaniadonovani, leptospira, measles/mumps/rubella, Mycobacterium leprae,Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenzavirus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa,respiratory syncytial virus, rickettsia (scrub typhus), Schistosomamansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosomacruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellowfever virus); specific antigens (hepatitis B virus, HIV-1);succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine(T4); thyroxine-binding globulin; trace elements; transferring;UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A;white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat,vitamins, and hormones naturally occurring in blood or interstitialfluids can also constitute analytes in certain embodiments. The analytecan be naturally present in the biological fluid, for example, ametabolic product, a hormone, an antigen, an antibody, and the like.Alternatively, the analyte can be introduced into the body, for example,a contrast agent for imaging, a radioisotope, a chemical agent, afluorocarbon-based synthetic blood, or a drug or pharmaceuticalcomposition, including but not limited to insulin; ethanol; cannabis(marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide,amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine(crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin,Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine);depressants (barbituates, methaqualone, tranquilizers such as Valium,Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens(phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics(heroin, codeine, morphine, opium, meperidine, Percocet, Percodan,Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogsof fentanyl, meperidine, amphetamines, methamphetamines, andphencyclidine, for example, Ecstasy); anabolic steroids; and nicotine.The metabolic products of drugs and pharmaceutical compositions are alsocontemplated analytes. Analytes such as neurochemicals and otherchemicals generated within the body can also be analyzed, such as, forexample, ascorbic acid, uric acid, dopamine, noradrenaline,3-methoxytyramine (3MT), 3,4-Dihydroxyphenylacetic acid (DOPAC),Homovanillic acid (HVA), 5-Hydroxytryptamine (5HT), and5-Hydroxyindoleacetic acid (FHIAA).

Alerts

In certain embodiments, one or more alerts are associated with a sensorelectronics module. For example, each alert may include one or morealert conditions that indicate when the respective alert has beentriggered. For example, a hypoglycemic alert may include alertconditions indicating a minimum glucose level. The alert conditions mayalso be based on transformed sensor data, such as trending data, and/orsensor data from multiple different sensors (e.g. an alert may be basedon sensor data from both a glucose sensor and a temperature sensor). Forexample, a hypoglycemic alert may include alert conditions indicating aminimum required trend in the host's glucose level that must be presentbefore triggering the alert. The term “trend,” as used herein refersgenerally to data indicating some attribute of data that is acquiredover time, e.g., such as calibrated or filtered data from a continuousglucose sensor. A trend may indicate amplitude, rate of change,acceleration, direction, etc., of data, such as sensor data, includingtransformed or raw sensor data.

In certain embodiments, each of the alerts is associated with one ormore actions that are to be performed in response to triggering of thealert. Alert actions may include, for example, activating an alarm, suchas displaying information on a display of the sensor electronics moduleor activating an audible or vibratory alarm coupled to the sensorelectronics module, and/or transmitting data to one or more displaydevices external to the sensor electronics module. For any deliveryaction that is associated with a triggered alert, one or more deliveryoptions define the content and/or format of the data to be transmitted,the device to which the data is to be transmitted, when the data is tobe transmitted, and/or a communication protocol for delivery of thedata.

In certain embodiments, multiple delivery actions (each havingrespective delivery options) may be associated with a single alert suchthat displayable sensor information having different content andformatting, for example, is transmitted to respective display devices inresponse to triggering of a single alert. For example, a mobiletelephone may receive a data package including minimal displayablesensor information (that may be formatted specifically for display onthe mobile telephone), while a desktop computer may receive a datapackage including most (or all) of the displayable sensor informationthat is generated by the sensor electronics module in response totriggering of a common alert. Advantageously, the sensor electronicsmodule is not tied to a single display device, rather it is configuredto communicate with a plurality of different display devices directly,systematically, simultaneously (e.g., via broadcasting), regularly,periodically, randomly, on-demand, in response to a query, based onalerts or alarms, and/or the like.

In some embodiments, clinical risk alerts are provided that includealert conditions that combine intelligent and dynamic estimativealgorithms that estimate present or predicted danger with greateraccuracy, more timeliness in pending danger, avoidance of false alarms,and less annoyance for the patient. In general, clinical risk alertsinclude dynamic and intelligent estimative algorithms based on analytevalue, rate of change, acceleration, clinical risk, statisticalprobabilities, known physiological constraints, and/or individualphysiological patterns, thereby providing more appropriate, clinicallysafe, and patient-friendly alarms. Co-pending U.S. Patent PublicationNo. 2007/0208246, which is incorporated herein by reference in itsentirety, describes some systems and methods associated with theclinical risk alerts (or alarms) described herein. In some embodiments,clinical risk alerts can be triggered for a predetermined time period toallow for the user to attend to his/her condition. Additionally, theclinical risk alerts can be de-activated when leaving a clinical riskzone so as not to annoy the patient by repeated clinical alarms (e.g.,visual, audible or vibratory), when the patient's condition isimproving. In some embodiments, dynamic and intelligent estimationdetermines a possibility of the patient avoiding clinical risk, based onthe analyte concentration, the rate of change, and other aspects of thedynamic and intelligent estimative algorithms. If there is minimal or nopossibility of avoiding the clinical risk, a clinical risk alert will betriggered. However, if there is a possibility of avoiding the clinicalrisk, the system is configured to wait a predetermined amount of timeand re-analyze the possibility of avoiding the clinical risk. In someembodiments, when there is a possibility of avoiding the clinical risk,the system is further configured to provide targets, therapyrecommendations, or other information that can aid the patient inproactively avoiding the clinical risk.

In some embodiments, the sensor electronics module is configured tosearch for one or more display devices within communication range of thesensor electronics module and to wirelessly communicate sensorinformation (e.g., a data package including displayable sensorinformation, one or more alarm conditions, and/or other alarminformation) thereto. Accordingly, the display device is configured todisplay at least some of the sensor information and/or alarm the host(and/or care taker), wherein the alarm mechanism is located on thedisplay device.

In some embodiments, the sensor electronics module is configured toprovide one or a plurality of different alarms via the sensorelectronics module and/or via transmission of a data package indicatingan alarm should be initiated by one or a plurality of display devices(e.g., sequentially and/or simultaneously). In certain embodiments, thesensor electronics module merely provides a data field indicating thatan alarm conditions exists and the display device, upon reading the datafield indicating the existence of the alarm condition, may decide totrigger an alarm. In some embodiments, the sensor electronics moduledetermines which of the one or more alarms to trigger based on one ormore alerts that are triggered. For example, when an alert triggerindicates severe hypoglycemia, the sensor electronics module can performmultiple actions, such as activating an alarm on the sensor electronicsmodule, transmitting a data package to a monitoring device indicatingactivation of an alarm on the display, and transmitting a data packageas a text message to a care provider. As an example, a text message canappear on a custom monitoring device, cell phone, pager device, and/orthe like, including displayable sensor information that indicates thehost's condition (e.g., “severe hypoglycemia”).

In some embodiments, the sensor electronics module is configured to waita time period for the host to respond to a triggered alert (e.g., bypressing or selecting a snooze and/or off function and/or button on thesensor electronics module and/or a display device), after whichadditional alerts are triggered (e.g., in an escalating manner) untilone or more alerts are responded to. In some embodiments, the sensorelectronics module is configured to send control signals (e.g., a stopsignal) to a medical device associated with an alarm condition (e.g.,hypoglycemia), such as an insulin pump, wherein the stop alert triggersa stop of insulin delivery via the pump.

In some embodiments, the sensor electronics module is configured todirectly, systematically, simultaneously (e.g., via broadcasting),regularly, periodically, randomly, on-demand, in response to a query(from the display device), based on alerts or alarms, and/or the liketransmit alarm information. In some embodiments, the system furtherincludes a repeater such that the wireless communication distance of thesensor electronics module can be increased, for example, to 10, 20, 30,50 75, 100, 150, or 200 meters or more, wherein the repeater isconfigured to repeat a wireless communication from the sensorelectronics module to the display device located remotely from thesensor electronics module. A repeater can be useful to families havingchildren with diabetes. For example, to allow a parent to carry, orplace in a stationary position, a display device, such as in a largehouse wherein the parents sleep at a distance from the child.

Display Devices

In some embodiments, the sensor electronics module is configured tosearch for and/or attempt wireless communication with a display devicefrom a list of display devices. In some embodiments, the sensorelectronics module is configured to search for and/or attempt wirelesscommunication with a list of display devices in a predetermined and/orprogrammable order (e.g., grading and/or escalating), for example,wherein a failed attempt at communication with and/or alarming with afirst display device triggers an attempt at communication with and/oralarming with a second display device, and so on. In one exemplaryembodiment, the sensor electronics module is configured to search forand attempt to alarm a host or care provider sequentially using a listof display devices, such as: 1) a default display device or a customanalyte monitoring device, 2) a mobile phone via auditory and/or visualmethods, such as, text message to the host and/or care provider, voicemessage to the host and/or care provider, and/or 911), 3) a tablet, 4) asmart watch.

Depending on the embodiment, one or more display devices that receivedata packages from the sensor electronics module are “dummy displays”,wherein they display the displayable sensor information received fromthe sensor electronics module without additional processing (e.g.,prospective algorithmic processing necessary for real-time display ofsensor information). In some embodiments, the displayable sensorinformation comprises transformed sensor data that does not requireprocessing by the display device prior to display of the displayablesensor information. Some display devices may comprise software includingdisplay instructions (software programming comprising instructionsconfigured to display the displayable sensor information and optionallyquery the sensor electronics module to obtain the displayable sensorinformation) configured to enable display of the displayable sensorinformation thereon. In some embodiments, the display device isprogrammed with the display instructions at the manufacturer and caninclude security and/or authentication to avoid plagiarism of thedisplay device. In some embodiments, a display device is configured todisplay the displayable sensor information via a downloadable program(for example, a downloadable Java Script via the internet), such thatany display device that supports downloading of a program (for example,any display device that supports Java applets) therefore can beconfigured to display displayable sensor information (e.g., mobilephones, tablets, PDAs, PCs and the like).

In some embodiments, certain display devices may be in direct wirelesscommunication with the sensor electronics module, however intermediatenetwork hardware, firmware, and/or software can be included within thedirect wireless communication. In some embodiments, a repeater (e.g., aBluetooth repeater) can be used to re-transmit the transmitteddisplayable sensor information to a location farther away than theimmediate range of the telemetry module of the sensor electronicsmodule, wherein the repeater enables direct wireless communication whensubstantive processing of the displayable sensor information does notoccur. In some embodiments, a receiver (e.g., Bluetooth receiver) can beused to re-transmit the transmitted displayable sensor information,possibly in a different format, such as in a text message onto a TVscreen, wherein the receiver enables direct wireless communication whensubstantive processing of the sensor information does not occur. Incertain embodiments, the sensor electronics module directly wirelesslytransmits displayable sensor information to one or a plurality ofdisplay devices, such that the displayable sensor informationtransmitted from the sensor electronics module is received by thedisplay device without intermediate processing of the displayable sensorinformation.

In certain embodiments, one or more display devices comprise built-inauthentication mechanisms, wherein authentication is required forcommunication between the sensor electronics module and the displaydevice. In some embodiments, to authenticate the data communicationbetween the sensor electronics module and display devices, achallenge-response protocol, such as a password authentication isprovided, where the challenge is a request for the password and thevalid response is the correct password, such that pairing of the sensorelectronics module with the display devices can be accomplished by theuser and/or manufacturer via the password.

In some embodiments, one or more display devices are configured to querythe sensor electronics module for displayable sensor information,wherein the display device acts as a master device requesting sensorinformation from the sensor electronics module (e.g., a slave device)on-demand, for example, in response to a query. In some embodiments, thesensor electronics module is configured for periodic, systematic,regular, and/or periodic transmission of sensor information to one ormore display devices (for example, every 1, 2, 5, or 10 minutes ormore). In some embodiments, the sensor electronics module is configuredto transmit data packages associated with a triggered alert (e.g.,triggered by one or more alert conditions). However, any combination ofthe above described statuses of data transmission can be implementedwith any combination of paired sensor electronics module and displaydevice(s). For example, one or more display devices can be configuredfor querying the sensor electronics module database and for receivingalarm information triggered by one or more alarm conditions being met.Additionally, the sensor electronics module can be configured forperiodic transmission of sensor information to one or more displaydevices (the same or different display devices as described in theprevious example), whereby a system can include display devices thatfunction differently with regard to how they obtain sensor information.

In some embodiments, as described in more detail elsewhere herein, adisplay device is configured to query the data storage memory in thesensor electronics module for certain types of data content, includingdirect queries into a database in the sensor electronics module's memoryand/or requests for configured or configurable packages of data contenttherefrom; namely, the data stored in the sensor electronics module isconfigurable, queryable, predetermined, and/or pre-packaged, based onthe display device with which the sensor electronics module iscommunicating. In some additional or alternative embodiments, the sensorelectronics module generates the displayable sensor information based onits knowledge of which display device is to receive a particulartransmission. Additionally, some display devices are capable ofobtaining calibration information and wireles sly transmitting thecalibration information to the sensor electronics module, such asthrough manual entry of the calibration information, automatic deliveryof the calibration information, and/or an integral reference analytemonitor incorporated into the display device. U.S. Patent PublicationNos. 2006/0222566, 2007/0203966, 2007/0208245, and 2005/0154271, all ofwhich are incorporated herein by reference in their entirety, describesystems and methods for providing an integral reference analyte monitorincorporated into a display device and/or other calibration methods thatcan be implemented with embodiments disclosed herein.

In general, a plurality of display devices (e.g., a custom analytemonitoring device, a mobile phone, a tablet, a smart watch, a referenceanalyte monitor, a drug delivery device, a medical device and a personalcomputer) are configured to wirelessly communicate with the sensorelectronics module, wherein the one or more display devices areconfigured to display at least some of the displayable sensorinformation wirelessly communicated from the sensor electronics module,wherein displayable sensor information includes sensor data, such as rawdata and/or transformed sensor data, such as analyte concentrationvalues, rate of change information, trend information, alertinformation, sensor diagnostic information and/or calibrationinformation, for example.

Exemplary Configurations

FIG. 1 is a diagram depicting an exemplary continuous analyte monitoringsystem 100 including an analyte sensor system 8 and a plurality ofdisplay devices 110, 120, 130, 140 according to certain aspects of thepresent disclosure. The analyte sensor system 8 includes a sensorelectronics module 12 and a continuous analyte sensor 10 associated withthe sensor electronics module 12. The sensor electronics module 12 is indirect wireless communication with one or more of the plurality of thedisplay devices 110, 120, 130, and/or 140 shown.

In certain embodiments, the sensor electronics module 12 includeselectronic circuitry associated with measuring and processing thecontinuous analyte sensor data, including prospective algorithmsassociated with processing and calibration of the sensor data. Thesensor electronics module 12 can be physically connected to thecontinuous analyte sensor 10 and can be integral with (non-releasablyattached to) or releasably attachable to the continuous analyte sensor10. The sensor electronics module 12 may include hardware, firmware,and/or software that enables measurement of levels of the analyte via aglucose sensor. For example, the sensor electronics module 12 caninclude a potentiostat, a power source for providing power to thesensor, other components useful for signal processing and data storage,and a telemetry module for transmitting data from the sensor electronicsmodule to one or more display devices. Electronics can be affixed to aprinted circuit board (PCB), or the like, and can take a variety offorms. For example, the electronics can take the form of an integratedcircuit (IC), such as an Application-Specific Integrated Circuit (ASIC),a microcontroller, and/or a processor. The sensor electronics module 12includes sensor electronics that are configured to process sensorinformation, such as sensor data, and generate transformed sensor dataand displayable sensor information. Examples of systems and methods forprocessing sensor analyte data are described in more detail herein andin U.S. Pat. Nos. 7,310,544 and 6,931,327 and U.S. Patent PublicationNos. 2005/0043598, 2007/0032706, 2007/0016381, 2008/0033254,2005/0203360, 2005/0154271, 2005/0192557, 2006/0222566, 2007/0203966 and2007/0208245, all of which are incorporated herein by reference in theirentirety for all purposes.

Referring again to FIG. 1, the plurality of display devices (110, 120,130, and/or 140) are configured for displaying (and/or alarming) thedisplayable sensor information that has been transmitted by the sensorelectronics module 12 (e.g., in a customized data package that istransmitted to the display devices based on their respectivepreferences). Each of the display devices 110, 120, 130, or 140 caninclude a display such as a touchscreen display 112, 122, 132, /or 142for displaying sensor information to a user and/or receiving inputs fromthe user. In some embodiments, the display devices may include othertypes of user interfaces such as voice user interface instead of or inaddition to a touchscreen display for communicating sensor informationto the user of the display device and/or receiving user inputs. In someembodiments, one, some or all of the display devices is configured todisplay or otherwise communicate the sensor information as it iscommunicated from the sensor electronics module (e.g., in a data packagethat is transmitted to respective display devices), without anyadditional prospective processing required for calibration and real-timedisplay of the sensor data.

In the embodiment of FIG. 1, the plurality of display devices includes acustom display device 110 specially designed for displaying certaintypes of displayable sensor information associated with analyte valuesreceived from the sensor electronics module 12 (e.g., a numerical valueand an arrow, in some embodiments). In some embodiments, one of theplurality of display devices is a mobile phone 120 based on an Androidor iOS operating system, a palm-top computer and/or the like, whereinthe display device comprises a relatively larger display and isconfigured to display a graphical representation of the continuoussensor data (e.g., including current and historic data). Other displaydevices can include other hand-held devices, such as a tablet 130, asmart watch 140, an insulin delivery device, a blood glucose meter,and/or a desktop or laptop computer.

Because different display devices provide different user interfaces,content of the data packages (e.g., amount, format, and/or type of datato be displayed, alarms, and the like) can be customized (e.g.,programmed differently by the manufacture and/or by an end user) foreach particular display device. Accordingly, in the embodiment of FIG.1, a plurality of different display devices can be in direct wirelesscommunication with the sensor electronics module (e.g., such as anon-skin sensor electronics module 12 that is physically connected to thecontinuous analyte sensor 10) during a sensor session to enable aplurality of different types and/or levels of display and/orfunctionality associated with the displayable sensor information, whichis described in more detail elsewhere herein.

Continuous Sensor

In some embodiments, analyte sensor 10 of FIG. 1 comprises a continuousglucose sensor, for example a subcutaneous, transdermal (e.g.,transcutaneous), or intravascular device. In some embodiments, thedevice can analyze a plurality of intermittent blood samples. Theglucose sensor can use any method of glucose-measurement, includingenzymatic, chemical, physical, electrochemical, spectrophotometric,polarimetric, calorimetric, iontophoretic, radiometric, immunochemical,and the like.

A glucose sensor can use any known method, including invasive, minimallyinvasive, and non-invasive sensing techniques (e.g., fluorescentmonitoring), to provide a data stream indicative of the concentration ofglucose in a host. The data stream is typically a raw data signal, whichis converted into a calibrated and/or filtered data stream that is usedto provide a useful value of glucose to a user, such as a patient or acaretaker (e.g., a parent, a relative, a guardian, a teacher, a doctor,a nurse, or any other individual that has an interest in the wellbeingof the host).

A glucose sensor can be any device capable of measuring theconcentration of glucose. One exemplary embodiment is described below,which utilizes an implantable glucose sensor. However, it should beunderstood that the devices and methods described herein can be appliedto any device capable of detecting a concentration of glucose andproviding an output signal that represents the concentration of glucose.

In certain embodiments, the analyte sensor is an implantable glucosesensor, such as described with reference to U.S. Pat. No. 6,001,067 andU.S. Patent Publication No. US-2005-0027463-A1. In another embodiment,the analyte sensor is a transcutaneous glucose sensor, such as describedwith reference to U.S. Patent Publication No. US-2006-0020187-A1. Instill other embodiments, the sensor is configured to be implanted in ahost vessel or extracorporeally, such as is described in U.S. PatentPublication No. US-2007-0027385-A1, co-pending U.S. Patent PublicationNo. US-2008-0119703-A1 filed Oct. 4, 2006, co-pending U.S. PatentPublication No. US-2008-0108942-A1 filed on Mar. 26, 2007, andco-pending U.S. Patent Application No. US-2007-0197890-A1 filed on Feb.14, 2007. In one alternative embodiment, the continuous glucose sensorcomprises a transcutaneous sensor such as described in U.S. Pat. No.6,565,509 to Say et al., for example. In another alternative embodiment,the continuous glucose sensor comprises a subcutaneous sensor such asdescribed with reference to U.S. Pat. No. 6,579,690 to Bonnecaze et al.or U.S. Pat. No. 6,484,046 to Say et al., for example. In anotheralternative embodiment, the continuous glucose sensor comprises arefillable subcutaneous sensor such as described with reference to U.S.Pat. No. 6,512,939 to Colvin et al., for example. In another alternativeembodiment, the continuous glucose sensor comprises an intravascularsensor such as described with reference to U.S. Pat. No. 6,477,395 toSchulman et al., for example. In another alternative embodiment, thecontinuous glucose sensor comprises an intravascular sensor such asdescribed with reference to U.S. Pat. No. 6,424,847 to Mastrototaro etal., for example.

FIGS. 2A and 2B are perspective and side views of an exemplary sensorsystem that can incorporate the analyte sensor system 8 shown in FIG. 1according certain aspects of the present disclosure. The sensor systemincludes a mounting unit 214 and sensor electronics module 12 attachedthereto in certain embodiments, shown in its functional position,including a mounting unit and a sensor electronics module matinglyengaged therein. In some embodiments, the mounting unit 214, alsoreferred to as a housing or sensor pod, comprises a base 234 adapted forfastening to a host's skin. The base can be formed from a variety ofhard or soft materials, and can comprises a low profile for minimizingprotrusion of the device from the host during use. In some embodiments,the base 234 is formed at least partially from a flexible material,which is believed to provide numerous advantages over conventionaltranscutaneous sensors, which, unfortunately, can suffer frommotion-related artifacts associated with the host's movement when thehost is using the device. The mounting unit 214 and/or sensorelectronics module 12 can be located over the sensor insertion site toprotect the site and/or provide a minimal footprint (utilization ofsurface area of the host's skin).

In some embodiments, a detachable connection between the mounting unit214 and sensor electronics module 12 is provided, which enables improvedmanufacturability, namely, the relatively inexpensive mounting unit 214can be disposed of when replacing the sensor system after its usablelife, while the relatively more expensive sensor electronics module 12can be reusable with multiple sensor systems. In some embodiments, thesensor electronics module 12 is configured with signal processing(programming), for example, configured to filter, calibrate and/or otheralgorithms useful for calibration and/or display of sensor information.However, an integral (non-detachable) sensor electronics module can beconfigured.

In some embodiments, the contacts 238 are mounted on or in a subassemblyhereinafter referred to as a contact subassembly 236 configured to fitwithin the base 234 of the mounting unit 214 and a hinge 248 that allowsthe contact subassembly 236 to pivot between a first position (forinsertion) and a second position (for use) relative to the mounting unit214. The term “hinge” as used herein is a broad term and is used in itsordinary sense, including, without limitation, to refer to any of avariety of pivoting, articulating, and/or hinging mechanisms, such as anadhesive hinge, a sliding joint, and the like; the term hinge does notnecessarily imply a fulcrum or fixed point about which the articulationoccurs. In some embodiments, the contacts 238 are formed from aconductive elastomeric material, such as a carbon black elastomer,through which the sensor 10 extends.

In certain embodiments, the mounting unit 214 is provided with anadhesive pad 208, disposed on the mounting unit's back surface andincludes a releasable backing layer. Thus, removing the backing layerand pressing the base portion 234 of the mounting unit onto the host'sskin adheres the mounting unit 214 to the host's skin. Additionally oralternatively, an adhesive pad can be placed over some or all of thesensor system after sensor insertion is complete to ensure adhesion, andoptionally to ensure an airtight seal or watertight seal around thewound exit-site (or sensor insertion site) (not shown). Appropriateadhesive pads can be chosen and designed to stretch, elongate, conformto, and/or aerate the region (e.g., host's skin). The embodimentsdescribed with reference to FIGS. 2A and 2B are described in more detailwith reference to U.S. Pat. No. 7,310,544, which is incorporated hereinby reference in its entirety. Configurations and arrangements canprovide water resistant, waterproof, and/or hermetically sealedproperties associated with the mounting unit/sensor electronics moduleembodiments described herein.

Various methods and devices that are suitable for use in conjunctionwith aspects of some embodiments are disclosed in U.S. PatentPublication No. US-2009-0240120-A1, which is incorporated herein byreference in its entirety for all purposes.

FIG. 3 is an exemplary block diagram illustrating various elements ofcertain embodiments of a continuous analyte monitoring system 300comprising analyte sensor system 8 and display devices 110, 120, 130,140. The analyte sensor system 8 may include an analyte sensor 312 (alsodesignated 10 in FIG. 1) coupled to a sensor measurement circuit 310 forprocessing and managing sensor data. The sensor measurement circuit 310may be coupled to a processor 314 (part of item 12 in FIG. 1). In someembodiments, the processor 314 may perform part or all of the functionsof the sensor measurement circuit 310 for obtaining and processingsensor measurement values from the sensor 312. The processor may befurther coupled to a radio unit or transceiver 316 (part of item 12 inFIG. 1) for sending sensor data and receiving requests and commands froman external device, such as the display device 110, 120, 130, 140, whichis used to display or otherwise provide the sensor data to a user. Asused herein, the terms “radio unit” and “transceiver” are usedinterchangeably and generally refer to a device that can wirelesslytransmit and receive data. The analyte sensor system 8 may furtherinclude a memory 318 (part of item 12 in FIG. 1) and a real time clock(RTC) 320 (part of item 12 in FIG. 1) for storing and tracking sensordata.

Wireless communication protocols may be used to transmit and receivedata between the sensor system 8 and the display device 110, 120, 130,140. The wireless protocol used may be designed for use in a wirelesssensor network that is optimized for periodic and small datatransmissions (that may be transmitted at low rates if necessary) to andfrom multiple devices in a close range (e.g., a personal area network(PAN)). For example, the protocol may be optimized for periodic datatransfers where transceivers may be configured to transmit data forshort intervals and then enter low power modes for long intervals. Theprotocol may have low overhead requirements both for normal datatransmissions and for initially setting up communication channels (e.g.,by reducing header overhead) to reduce power consumption. In someembodiments, burst broadcasting schemes (e.g., one way communication)may be used. This may eliminate overhead required for acknowledgementsignals and allow for periodic transmissions that consume little power.

The protocol may further be configured to establish communicationchannels with multiple devices while implementing interference avoidanceschemes. In some embodiments, the protocol may make use of adaptiveisochronous network topologies that define various time slots andfrequency bands for communication with several devices. The protocol maythus modify transmission windows and frequencies in response tointerference and to support communication with multiple devices.Accordingly, the wireless protocol may use time and frequency divisionmultiplexing (TDMA) based schemes. The wireless protocol may also employdirect sequence spread spectrum (DSSS) and frequency-hopping spreadspectrum schemes. Various network topologies may be used to supportshort-distance and/or low-power wireless communication such aspeer-to-peer, start, tree, or mesh network topologies such as WiFi,Bluetooth and Bluetooth Low Energy (BLE). The wireless protocol mayoperate in various frequency bands such as an open ISM band such as 2.4GHz. Furthermore, to reduce power usage, the wireless protocol mayadaptively configure data rates according to power consumption.

The display device 110, 120, 130, 140 may be used for alerting andproviding sensor information to a user, and may include a processor 330for processing and managing sensor data. The display device 110, 120,130, 140 may include a display 332, a memory 334, and a real time clock336 for displaying, storing and tracking sensor data respectively. Thedisplay device 110, 120, 130, 140 may further include a radio unit ortransceiver 338 for receiving sensor data and for sending requests,instructions, and data to the analyte sensor system 8. The transceiver338 may further employ a communication protocol. The memory 334 may alsobe used for storing an operating system for the display device and/or acustom (e.g., proprietary) application designed for wireless datacommunication between a transceiver and the display device. The memory334 may be a single memory device or multiple memory devices and may bea volatile or non-volatile memory for storing data and/or instructionsfor software programs and applications. The instructions may be executedby the processor 330 to control and manage the transceiver 338.

In some embodiments, when a standardized communication protocol is used,commercially available transceiver circuits may be utilized thatincorporate processing circuitry to handle low level data communicationfunctions such as the management of data encoding, transmissionfrequencies, handshake protocols, and the like. In these embodiments,the processor 314, 330 does not need to manage these activities, butrather provides desired data values for transmission, and manages highlevel functions such as power up or down, set a rate at which messagesare transmitted, and the like. Instructions and data values forperforming these high level functions can be provided to the transceivercircuits via a data bus and transfer protocol established by themanufacturer of the transceiver circuit 316.

Components of the analyte sensor system 8 may require replacementperiodically. For example, the analyte sensor system 8 may include animplantable sensor 312 that may be attached to a sensor electronicsmodule that includes the sensor measurement circuit 310, the processor314, memory 318, and transceiver 316, and battery (not shown). Thesensor 312 may require periodic replacement (e.g., every 7-30 days). Thesensor electronics module may be configured to be powered and active formuch longer than the sensor 312 (e.g., for three, six months or more)until the battery needs replacement. Replacing these components may bedifficult and require the assistance of trained personnel. Reducing theneed to replace such components, particularly the battery, significantlyimproves the convenience of the analyte sensor system 8 to the user. Insome embodiments, the sensor session as defined above may correspond tothe life of the sensor 312 (e.g., in the range of 7 to 30 days). When asensor electronic module is used for the first time (or reactivated oncea battery has been replaced in some cases), it may be connected to asensor 312 and a sensor session may be established. As will be furtherdescribed below, there may be a process for initially establishingcommunication between a display device 110, 120, 130, 140 and the sensorelectronics module when it is first used or re-activated (e.g., thebattery is replaced). Once the display device 110, 120, 130, 140 andsensor electronics module have established communication, the displaydevice 110, 120, 130, 140 and sensor electronics module may periodicallyand/or continuously be in communication over the life of several sensors312 until, for example, the battery needs to be replaced. Each time asensor 312 is replaced, a new sensor session may be established. The newsensor session may be initiated through a process completed using adisplay device 110, 120, 130, 140 and the process may be triggered bynotifications of a new sensor via the communication between the sensorelectronics module and the display device 110, 120, 130, 140 that may bepersistent across sensor sessions.

The analyte sensor system 8 gathers analyte data from the sensor 312that it periodically sends to the display device 110, 120, 130, 140.Data points are gathered and transmitted over the life of the sensor(e.g., in the range of 1 to 30 days or more). New measurements may needto be transmitted often enough to adequately monitor glucose levels.Rather than having the transmission and receiving circuitry of each ofthe sensor system 8 and display device 110, 120, 130, 140 continuouslycommunicating, the analyte sensor system 8 and display device 110, 120,130, 140 may regularly and periodically establish a communicationchannel between them. Thus, sensor system 8 can communicate via wirelesstransmission with display device 110, 120, 130, 140 (e.g., a hand-heldcomputing device) at predetermined time intervals. The duration of thepredetermined time interval can be selected to be long enough so thatthe sensor system 8 does not consume too much power by transmitting datamore frequently than needed, yet frequent enough to providesubstantially real-time sensor information (e.g., measured glucosevalues) to the display device 110, 120, 130, 140 for output (e.g.,display) to a user. While the predetermined time interval is every fiveminutes in some embodiments, it is appreciated that this time intervalcan be varied to be any desired length of time.

FIG. 4 is a flow diagram illustrating an exemplary wireless datacommunication procedure between an analyte sensor system 8 and a displaydevice 110, 120, 130, 140 capable of wirelessly receiving analyte valuesfrom the analyte sensor system 8 according to certain aspects of thepresent disclosure. The various tasks performed in connection with theprocedure illustrated in FIG. 4 may be performed by a processorexecuting instructions embodied in non-transitory computer-readablemedium. For example, the tasks performed in connection with theprocedure may be performed by hardware, software, firmware, or anycombination thereof incorporated into one or more of computing devices,such as one or more of sensor system 8 and display devices 110, 120, 130and 140 of FIG. 1 and/or FIG. 3. It should be appreciated that theprocedure may include any number of additional or alternative tasks. Thetasks shown in FIG. 4 need not be performed in the illustrated order,and the procedure may be incorporated into a more comprehensiveprocedure or process having additional functionality not described indetail herein.

In the example described below, the analyte values are glucose valuesbased on one or more measurements of glucose level by the analyte sensor312 for illustration purposes. However, it should be understood that theanalyte values can be any other analyte value described herein. Thewireless data communication between the analyte sensor system 8 and thedisplay device may happen periodically, at times separated by an updateinterval denoted “T_(interval)” that may correspond to a time durationbetween two consecutive wireless communication sessions between thetransceiver 316 of the analyte sensor system 8 and the transceiver 338of the display device 110, 120, 130, 140. Alternatively, the updateinterval may be thought of as a period of obtaining and sending arecently measured glucose value. Transmitting advertisement signals,establishing a data connection (e.g., a communication channel) andrequesting and sending data may occur during wireless communicationsessions each lasting an active time or period denoted “T_(Active)”within an update interval T_(interval). In between two consecutivewireless communication sessions, the transceiver 316 goes into aninactive or sleep mode for an inactive period denoted as “T_(Inactive)”to conserve battery life and/or reduce peak voltage requirements, forexample.

FIG. 4 shows two such wireless communication sessions, namely, a firstwireless communication session 410 and a second wireless communicationsession 420. Each wireless communication session 410, 420 starts withthe analyte sensor system 8 establishing a data connection with adisplay device 110, 120, 130, 140. To establish a data connection withthe display device 110, 120, 130, 140, the transceiver 316 of theanalyte sensor system 8 transmits a series of advertisement signals 412during the first wireless communication session 420. Each advertisementsignal may be considered an invitation for a display device 110, 120,130, 140 to establish a data connection with the transceiver 316.

In the illustrated example of FIG. 4, it is assumed that the analytesensor system 8 needs to engage in an initial system setup because thesystem 8 has been just turned on for the first time and/or is currentlynot paired with a display device 110, 120, 130, 140. Typically, a userof the display device 110, 120, 130, 140 identifies a new or never-beenused analyte sensor system 8 that needs to be paired with the displaydevice by entering identification information (e.g., a serial number)associated with the new/unpaired analyte sensor system 8 via a customapplication running on the display device using a user interface (e.g.,a touchscreen display). During the first wireless communication session410, an authentication procedure needs to be performed as part of a dataconnection process 414. To establish a data connection with the analytesensor system 8, the display device 110, 120, 130, 140 listenscontinuously until an advertisement signal transmitted by thetransceiver 316 of the analyte sensor system 8 is received. Once thetransceiver 316 begins transmitting advertisement signals 412, it maytake one, two, or more advertisement signals for the display device 110,120, 130, 140 to receive the advertisement signal and responds to theadvertisement signal. In some embodiments, the transceiver 316 stopssending additional advertisement signals once a display device receivesan advertisement signal and responds to the advertisement signal, forexample, via an acknowledgement. In other embodiments, the transceiver316 may continue to send additional advertisement signals even afterreceiving a response from a display device so that another displaydevice may receive and respond to one of the additional advertisementsignals.

After an advertisement signal is successfully received by a displaydevice 110, 120, 130, 140, the display device and the analyte sensorsystem 8 engage in a first data connection process 414. During the firstdata connection process 414, the display device requests a challengevalue from the analyte sensor system 8 and the analyte sensor system 8sends the change value to the display device in response. Upon receivingthe challenge value, the display device calculates a hash value based onthe challenge value and the identification information associated withthe analyte sensor system 8 and/or the transceiver 316 and sends thehash value to the transceiver 316. The transceiver 316 receives the hashvalue from the display device 110, 120, 130, 140, decodes theidentification information from the hash value, and verifies that thereceived identification information matches identification informationassociated with the sensor system 8 and/or transceiver 316 previouslystored in the memory 318 of the analyte sensor system 8, such as duringmanufacturing of the sensor system 8. Upon verification, the transceiver316 sends a signal confirming a successful authentication to the displaydevice 110, 120, 130, 140. Once authenticated, the analyte sensor system8 and display device 110, 120, 130, 140 may exchange information todetermine how data will be exchanged (e.g., a specific frequency, timeslot assignment, encryption, etc.).

After completion of the first data connection process 414, the analytesensor system 8 and the connected display device 110, 120, 130, 140engage in a first data communication 416 during which the connecteddisplay device requests and receives desired information (e.g., analytedata, control information, identification information, and/orinstruction) from the analyte sensor system 8. When the first datacommunication 416 is completed, the data connection is terminated (e.g.,by closing the established communication channel) and the transceiver316 and/or the processor 314 of the analyte sensor system 8 (andpossibly the transceiver 338 and/or the processor 330 of the displaydevice 110, 120, 130, 140 as well, depending on implementationpreference) can be deactivated by causing the transceiver 316 and/or theprocessor 314 to enter a sleep or inactive mode. In some embodiments,the transceiver 316 is completely powered down during a sleep mode. Inother embodiments, the transceiver 316 is in a low power mode using onlya small fraction (e.g., 1-10%) of the normal current/power.

The active period T_(Active) corresponding to a duration of eachwireless communication session may be a small fraction of the updateinterval T_(interval) corresponding to a period between two consecutivewireless communication sessions. For example, T_(interval) may bebetween about 200 and 400 seconds and T_(Active) may be between 20 and40 seconds. As such, the transceiver 316 of the analyte sensor system 8may be powered fully for only 10 percent (e.g., 30 seconds) of a fiveminute T_(interval). This may significantly reduce power consumption andpeak voltage demand. In some cases, the transceiver 316 is notcompletely powered down, but enters a low-power mode when nottransmitting. After an inactive time or period T_(Inactive), a secondwireless communication session 420 starts when the transceiver 316 (andthe transceiver 338) powers up again, begins transmitting a secondseries of advertisement signals 422, engages in a second data connectionprocess 424 and a second data communication process 426 with thetransceiver 338 of the display device 110, 120, 130, 140 as shown inFIG. 4. Unlike the first data connection process 414, however, thesecond data connection process 424 does not involve an authenticationbecause the analyte sensor system 8 and the display device 110, 120,130, 140 have been successfully paired or bonded during the firstwireless communication session 410 as described above. This process maycontinue, with new data connections and communications being completedat the pre-determined intervals. During all or part of each inactiveperiod T_(Inactive) during which the transceiver 316 is in a sleep mode,the processor 314 can take measurement(s) of one or more analyte valuesusing the analyte sensor 312 and the sensor measurement circuitry 310.For example, the processor 314 may take multiple analyte valuemeasurements and average them to generate a single averaged analytevalue to be transmitted in a next wireless communication session.

Continuously re-establishing a new communication channel to allow forpartially or wholly powering down the transceiver 316 during each updateinterval T_(interval) can provide significant power savings and canallow the sensor electronics module 12 (FIG. 1) to operate continuouslyfor six months or more without requiring a battery replacement.Furthermore, rather than blindly transmitting glucose data points duringthe update interval Tintervai, establishing specific data connections(e.g., communication channels) with only the desired display devices110, 120, 130, 140 can prevent unauthorized use and interception ofglucose measurement values. In some embodiments, only a subset ofmultiple display devices 110, 120, 130, 140 can be configured to receivedifferent data such as glucose measurement values and/or alarmconditions. This has a benefit of preventing multiple display devicesfrom issuing alarms, thereby confusing and/or frustrating the user. Inaddition, by establishing a secure two-way communication channel,requests for specific glucose measurement values or communication ofcalibration or configuration information may be transmitted on anas-needed/requested basis between the analyte sensor system 8 anddisplay device 110, 120, 130, 140.

Also, in some embodiments, the transceiver 316 may not be activated fordata communication every update interval T_(interval). Instead, thetransceiver 316 may be activated every second, third or fourth updateinterval T_(interval), for example, so that communication between thesensor system 8 with the display device 110, 120, 130, 140 occurs lessfrequently than every update interval T_(interval). Doing so can furtherreduce power consumption. Activation could also depend on the sensordata. For example, only activate the transceiver if data meets certainthresholds, such a current rate of change, current high value, currentlow value, absolute difference from a previously exchanged value,percentage difference from a previously exchanged value, and the like.In some embodiments, instead of skipping certain fixed update intervals,the length of each interval can be made vary based on sensor data. Forexample, if the sensor data indicates a low glucose value and/or ahypoglycemic reaction is detected, the update interval value can beshortened from a normal update interval value so that more frequentreadings are taken and transmitted.

In some embodiments, the update interval T_(interval), the active periodT_(Active) and a frequency F_(Activation) by which the transceiver isactivated (e.g., every second, third or fourth update interval) may bevariable. In certain embodiments, the above-identified parameters can beuser configurable (e.g., by inputting a value for the variable usinguser interface of display device 110, 120, 130, 140) and/orautomatically varied by the analyte sensor system 8 or display device110, 120, 130, 140 based on one or more criteria. The criteria caninclude: (i) a monitored battery power of the sensor system 8, (ii) acurrently measured, previously measured and/or predicted glucoseconcentrations meeting or exceeding a predetermined threshold, (iii) aglucose concentration trend of the host based on currently measured,previously measured and/or predicted glucose concentrations, (iv) a rateof change of glucose concentration of the host based currently measured,previously measured and/or predicted glucose concentrations meeting orexceeding a predetermined threshold, (v) whether the host is determinedto be in or near hyperglycemia based on currently measured, previouslymeasured and/or predicted glucose concentrations, (vi) whether the hostis determined to be in or near hypoglycemia based on currently measured,previously measured and/or predicted glucose concentrations, (vii) userinputted activity of the host (e.g., exercising or sleeping), (viii)time since a sensor session has started (e.g., when a new sensor 10 isused), (ix) one or more errors detected by sensor system 8 or displaydevice 110, 120, 130, 140, and (x) type of display device.

T_(interval), T_(Active), F_(Activation) and/or other configurationitems described herein may form part of a communication protocol profilethat may be stored on any device that implements the fundamentalcommunication protocol to allow for a customized use of the protocol forcommunicating analyte measurement values in the analyte sensor system 10and display device 110, 120, 130, 140.

Facilitating Initial Data Connection Process

When a user wishes to pair a display device 110, 120, 130, 140 with anew analyte sensor system 8, he enters identification information (e.g.a serial number or some other unique identifier) associated with theanalyte sensor system 8 (or the transceiver 316 of the system 8) in thedisplay device, e.g., via a user interface (e.g., touchscreen) of thedisplay device. For example, depending on the programmed update intervalTintervai and/or any sensor system initialization time, it can take 5 to10 minutes before the transceiver 316 begins transmitting advertisementsignals. It can therefore take up to 10 minutes to pair the analytesensor system 8 with the display device 110, 120, 130, 140. In someembodiments the display device can be a mobile device such as a mobilephone 120, a tablet 130 or a smart watch 140 based on a particularmobile operating system (e.g., Android or iOS). A custom applicationrunning in the mobile device for handling an authentication procedurewith the analyte sensor system 8 may be in an inactive or backgroundmode so that the mobile device may not be able to complete theauthentication procedure when the transceiver 316 begins to transmitadvertisement signals. This problem can further increase the pairingtime.

One solution to the aforementioned problem is to cause the mobile deviceto display a message to the user via a user interface letting him knowthat the analyte sensor system 8 is ready for a data connection with themobile device so that he can bring the custom application into aforeground mode. Once in the foreground mode, the custom application canoptionally ask the user for confirmation that a data connection with thetransceiver is desired. FIG. 5 is a flowchart illustrating an exemplaryprocess 500 for facilitating an initial setup procedure between ananalyte sensor system 8 and a mobile device 120, 130, 140 accordingcertain aspects of the present disclosure. The various tasks performedin connection with the process 500 illustrated in FIG. 5 may beperformed by a processor executing instructions embodied innon-transitory computer-readable medium. For example, the tasksperformed in connection with the process 500 may be performed byhardware, software, firmware, or any combination thereof incorporatedinto one or more of computing devices, such as one or more of sensorsystem 8 and display devices 110, 120, 130 and 140 of FIG. 1 and/or FIG.3. It should be appreciated that the procedure may include any number ofadditional or alternative tasks. The tasks shown in FIG. 5 need not beperformed in the illustrated order, and the procedure may beincorporated into a more comprehensive procedure or process havingadditional functionality not described in detail herein.

As indicated above, the mobile device 120, 130, 140 can be based on amobile operating system such as Android or iOS. The mobile device can bealso configured to run a custom application for handling communicationand management of analyte data from the analyte sensor system 8. Incertain embodiments, the wireless data communication is based on ashort-distance and/or low-power wireless communication protocol such asWiFi, Bluetooth and Bluetooth low energy (BLE). In certain embodiments,the mobile device is an iOS-based iPhone and the wireless communicationprotocol is the BLE.

The process 500 begins at a start state 501 and proceeds to operation510 where the mobile device 120, 130, 140 reads identificationinformation associated with the transceiver 316 of the analyte sensorsystem 8 that the user wishes to pair with. The identificationinformation can be a serial number associated with the sensor system,for example. The user may enter this information via the customapplication using a user interface such as a touchscreen display 122,132, 142 provided in the mobile device 120, 130, 140. The process 500proceeds to operation 520 where the user-entered identificationinformation is stored in a memory 334 of the mobile device 120, 130,140. The process 500 proceeds to operation 530 where the processor 330of the mobile device 120, 130, 140 causes the custom application toenter a background mode. The custom application can be made to enter abackground mode for a variety of reasons. For example, in certainembodiments, the background mode is entered after a predetermined timeof inactivity. Depending on the mobile operating system, thepredetermined time of inactivity can be between 10 and 100 seconds. Insome embodiments, the background mode is entered after detectingconditions such as the memory usage of the mobile device exceeding somepredetermined threshold and the mobile operating system and/or the userdecides to place one or more active applications into a background mode.

The process 500 then proceeds to operation 540 where the mobile device120, 130, 140 searches for advertisement signals from the transceiver316 until the mobile device receives an advertisement signal. Theprocess 500 proceeds to operation 550 where the mobile device,authenticates the transceiver 316 based on the user-enteredidentification information and a challenge value. As discussed abovewith respect to FIG. 4, the authentication operation 500 can include themobile device requesting a challenge value from the transceiver 316;receiving the challenge value; generating or calculating a hash valuefrom the challenge value and the identification information;transmitting the hash value to the transceiver; and receiving aconfirmation indicating a successful authentication from the transceiver316.

The process 500 then proceeds to operation 560 where the mobile device120, 130, 140 prompts (e.g. via one or a combination of any of anaudible alarm, vibratory alarm and pop up message) the user to bring thecustom application into a foreground mode, e.g., by touching an iconassociated with the custom application and/or the mobile device causes apop-up message to appear on the display prompting the user to touch aselectable field corresponding to a custom application. Once the customapplication is brought into a foreground mode, the process 500 proceedsto operation 570 where the custom application requests a confirmationfrom the user that a data connection with the transceiver 316 isdesired. The process 500 proceeds to a query state 575 where it isdetermined whether such a confirmation is received from the user withina predetermined time. If the confirmation is received (Yes), the process500 proceeds to operation 580 where the data connection with thetransceiver 316 is completed, e.g., by sending a signal indicating theconfirmation to the transceiver followed by a data communication inwhich the mobile device requests and receives an analyte value from thetransceiver 316. After the data connection and data communication arecompleted, the process 500 proceeds to operation 590 where the dataconnection is terminated and then ends at an end state 503. On the otherhand, if no confirmation is received from the user within apredetermined time (No), the process 500 ends without completing thepairing between the analyte sensor system 8 and the mobile device 120,130, 140.

By way of example, the process 500 described above can be implemented inan Apple iPhone with iOS7 operating system. The iOS7 has“Restore/Restoration function” that reminds iOS7 that a customapplication which has been suspended or placed in a background mode isexpecting another Bluetooth event. Prior to this event, iOS7 can wake upthe application and thereby cause it scan for Bluetooth signals (e.g.,advertisements) from the transceiver 316.

Bringing a Custom Application Back from a Suspended State

In some cases, the processor 300 in the mobile device 120, 130, 140 maysuspend the custom application if a certain condition occurs. Forexample, in some mobile operation systems, when it is determines thatone or more applications are using an excessive amount of memory, theoperating system may decide to deactivate or otherwise suspend one ormore of the application(s) including a custom application in the mobiledevice that facilitates wireless communication with the analyte sensorsystem 8. When such a deactivation or suspension of the customapplication occurs, the transceiver 338 in the mobile device may notscan or search for advertisement signals as often or at all, which inturn can hamper the ability of the mobile device to display updatedanalyte values and/or provide alerts based on the analyte values.

This problem can be solved by use of a reminder feature available insome mobile operating systems such as Apple, Inc.'s iOS7 mobileoperating system that reminds the operating system a custom applicationhas been suspended and that the application is expecting a wirelesscommunication event. In response to the reminder, the operating systemcan bring the custom application out of an inactive state (e.g.,suspended, closed, in background, etc.) or just know to activate the BLEradio, thereby allowing the custom application to get ready for theupcoming wireless communication event. FIG. 6 is a flowchartillustrating an exemplary process 600 for facilitating a wireless datacommunication between an analyte sensor system 8 and a mobile displaydevice 120, 130, 140 capable of wirelessly receiving analyte values fromthe analyte sensor system 8 by causing the custom application to exit aninactive state prior to a next scheduled data communication eventaccording certain aspects of the present disclosure.

The process 600 begins at a start state 601 and proceeds to operation610 where an excessive memory use by the custom application has beendetermined. An excessive memory use may be caused, for example, whenmemory usage on the mobile display device 110, 120, 130, 140 exceeds acertain preset storage threshold. An example can be a plurality ofapplications running on the mobile display device are using more memorythan desired, which can result in poor performance overall. The process600 proceeds to operation 610 where the processor 330 of the mobiledisplay device 110, 120, 130, 140 causes the custom application to enteran inactive state in order to reduce overall memory usage, for example.As described above, when the custom application is placed in an inactivestate, the transceiver 338 in the mobile device may be configured to notscan or search for advertisement signals as often or at all. The process600 then proceeds to operation 620 where the processor 330 determines anext scheduled time at which the transceiver 316 is expected to begintransmitting a next set of advertisement signals. The process 600proceeds to operation 630 where the processor 330 causes the customapplication to exit the in active state prior to the next scheduledtime. By bringing back the custom application from the suspended statebefore the transceiver 316 exits an inactive mode and beginstransmitting a next set of advertisement signals, the mobile device isable to receive an advertisement signal and engage in data connectionand communication with the transceiver 316. The process 600 ends at anend state 603 and then proceeds to requesting a connection andexchanging data as described above with respect to the operation 420 ofFIG. 4.

Minimizing the Number of Advertisement Signals to Establish a DataConnection

As described above with respect to FIG. 4, once the transceiver 316begins transmitting a set of advertisement signals 412, 422, it may takeseveral advertisement signals for the display device 110, 120, 130, 140to receive an advertisement signal and make a data connection with thetransceiver 316. In some cases, the number can be as high as 10 or more.Transmission of such a high number of advertisement signals can drain alot of power from the battery of the analyte sensor system 8. Thus,minimizing the number of advertisement signals that the transceiver 316transmits can prolong the life of the analyte sensor system 8. Incertain aspects of the present disclosure, this minimization can beachieved by causing the transceiver or radio unit 338 of the displaydevice 110, 120, 130, 140 to exit an inactive mode and actively scan foradvertisement signals from the transceiver 316 of the analyte sensorsystem 8 prior to the transmission of the advertisement signals. Theparticular time at which the transceiver 338 to exit the inactive modecan be calculated based on a connection interval received from theanalyte sensor system 8 from a previous wireless communication cycle.The connection interval is indicative of an amount of time elapsedbetween the beginning of transmission of a series of advertisementsignals by the transceiver 316 of the analyte sensor system 8 and areception of a data connection request from the display device 110, 120,130, 140 by the transceiver 316 in the previous wireless communicationcycle. This scheme prevents the transceiver 338 of the display device110, 120, 130, 140 from waking up too late and missing one or moreadvertisement signals at the beginning of the transmission.

FIG. 7 is a flowchart illustrating an exemplary process 700 forminimizing the number of advertisement signals that the transceiver 316of the analyte sensor system 8 transmits before establishing a dataconnection with the display device 110, 120, 130, 140 according certainaspects of the present disclosure. The flowchart shows two sets ofoperations. The set shown on the left-hand side with numerals rangingfrom 750 to 768 correspond to the operations performed at the displaydevice 110, 120, 130, 140; and the set shown on the right-hand side withnumerals ranging from 710 to 722 correspond to the operations performedat the analyte sensor system 8. The various tasks performed inconnection with the process 700 illustrated in FIG. 7 may be performedby a processor executing instructions embodied in non-transitorycomputer-readable medium. For example, the tasks performed in connectionwith the process 700 may be performed by hardware, software, firmware,or any combination thereof incorporated into one or more of computingdevices, such as one or more of sensor system 8 and display devices 110,120, 130 and 140 of FIG. 1 and/or FIG. 3. It should be appreciated thatthe procedure may include any number of additional or alternative tasks.The tasks shown in FIG. 7 need not be performed in the illustratedorder, and the procedure may be incorporated into a more comprehensiveprocedure or process having additional functionality not described indetail herein.

The process 700 begins at a start state 701 and proceeds to operation710 where, at the analyte sensor system 8, the transceiver 316 exitsfrom a sleep or inactive mode during which the transceiver 316 does notengage in a data communication with the display device 110, 120, 130,140.

At the display device 110, 120, 130, 140, the process 700 proceeds tooperation 750 where the processor 330 of the display device causes thetransceiver 338 to search for advertisement signals from the analytesensor system 8. At the analyte sensor system 8, the process 700proceeds to operation 712 where the processor 314 of the analyte sensorsystem 8 causes the transceiver 316 to begin transmitting a first seriesof advertisement signals at a first time Ti. The processor 314 of theanalyte sensor system 8 measures the first time T1 using the real timeclock (RTC) 320 and stores T1 in the memory 318.

At the display device 110, 120, 130, 140, the process 700 proceeds tooperation 752 where the processor 330 of the display device receives anadvertisement signal from the analyte sensor system 8 via thetransceiver 338. Subsequently at operation 754, the processor 330 causesthe transceiver 338 to transmit a data connection request to the analytesensor system 8. At the analyte sensor system 8, the process 700proceeds to operation 714 where the processor 314 receives the dataconnection request from the display device via the transceiver 316 at asecond time T2. The processor 314 measures the second time T2 using theRTC 320 and stores T2 in the memory 318. At operation 716, the processor314 grants the data connection request by causing the transceiver 316 totransmit a signal indicating the grant of the data connection request tothe display device 110, 120, 130, 140 and establishing a data connectionwith the display device. At the display device, the processor 330 of thedisplay device receives the signal from the analyte sensor system 8 andcauses the transceiver 338 to establish a data connection with thetransceiver 316 at operation 758.

At the analyte sensor system 8, the process 700 proceeds to operation718 where the processor 314 causes the transceiver 316 to transmit aconnection interval to the display device 110, 120, 130, 140. Theconnection interval is for use by the display device to calculate anexit time at which the display device is to exit from an inactive modeand start to search for advertisement signals from the analyte sensorsystem 8. The connection interval is calculated based on the first andsecond times, T1 and T2, and is indicative of a difference between thosetwo times. For example, in some embodiments, the connection interval isthe difference, namely, (T2−T1). In other embodiments, the connectioninterval is a function of the difference such as the currenttime+(T2−T1).

At the display device 110, 120, 130, 140, the process 700 proceeds tooperation 760 where the processor 330 receives the connection intervalfrom the analyte sensor system 8. The processor 330 then transmits arequest for an analyte value to the analyte sensor system 8 at operation762. At the analyte sensor system 8, the processor 314 receives therequest and transmits the analyte value to the display device atoperation 718 and causes the transceiver 316 to terminate the dataconnection at operation 720 and enter a sleep mode at operation 722. Insome embodiments, the transceiver 316 is completely powered down. Inother embodiments, the transceiver 316 enters a low-power mode.

At the display device 110, 120, 130, 140, the processor 330 receives theanalyte value and terminates the data connection with the analyte sensorsystem 8 at operation 762. The processor 330 also causes the transceiver338 to enter an inactive mode at operation 764. During the inactivemode, the transceiver 338 of the display device does not engage in awireless data communication with the transceiver 316 of the analytesensor system 8. At operation 766, the processor 330 also calculates anexit time at which the transceiver 316 is to exit the inactive modebased on the connection interval received from the analyte sensor system8. In certain embodiments, the calculated exit time is given by: currenttime+update interval (T_(interval))−the connection interval−notificationdelay−safeguard. As used herein, the notification delay is a measure oftime elapsed between when a connection is first established and when asynchronization notification is actually sent. The actual duration mightvary depending upon devices used. The safeguard is a measure of timethat display device transceiver 338 has to wake up, and start scanning,before the analyte sensor system transceiver 316 wakes up. In someembodiments, the connection interval is from about 90 to 300milliseconds and the notification delay is from about 100 to 300milliseconds and the safeguard is typically from about 300 to 700milliseconds. At operation 768, the processor 330 causes the transceiver338 to exit the inactive mode at the calculated exit time so that thetransceiver 338 can start searching for a next series of advertisementsignals from the transceiver 316 of the analyte sensor system 8.

As can be seen in FIG. 7, the process 700 subsequently repeats so that,for a given wireless communication session, the transceiver 338 of thedisplay device 110, 120, 130, 140 can exit from the inactive mode at anexit time that is calculated based on a connection interval receivedfrom the analyte sensor system 8 during a previous wirelesscommunication session. When implemented in a mobile device using anAndroid operating system, this scheme has been shown to reduce thenumber of advertisement signals that the transceiver 316 needs totransmit on the average from over 50 to about 3 to 4. Further, use ofthis scheme has realized a reduction in power consumption foradvertising by up to about 68% for the connection process.

Switching between Display Devices

In some cases, it may be desirable or necessary for a user to switchbetween two or more display devices. For example, the user may want tonormally view the glucose reading on his mobile phone 120. However, whenthe mobile phone 120 battery level is low, he may want to switch to thecustom monitoring device 110 to continue to view the glucose readingfrom there. After charging the mobile phone, the user may want to switchback to the mobile phone 120 for a better viewing experience. Therefore,a convenient and efficient way to switch between display devices isdesirable.

In addition, it is also desirable to be able to efficiently reject dataconnection requests from one or more display devices that are not theuser-selected display device. For example, in a situation where the userselected the mobile phone 120 to be the only allowed display device, butthe transceiver 316 may receive data connection requests from otherdisplay devices. In such cases, it is desirable to promptly reject thedata connection request without spending a lot of time and batterypower.

One solution for facilitating a switch between two display devices is toidentify the single allowed display device (the mobile phone 120 in theexample above) in a list and if a data connection request is receivedfrom a display device that is not the single allowed display deviceidentified in the list, reject the request at a radio hardware levelrather than at an upper software level. Such a list is can beimplemented in a memory associated a processor controlling functions ofthe transceiver 316 at a radio hardware level. Such a processor may bepart of the main processor 314 or part of the transceiver 316. In someembodiments, the processor is a link layer (LL) controller in theBluetooth low energy (BLE) architecture. When a data connection requestis received from a device, the radio hardware level controllerdetermines whether the requesting device is identified in the list and,if it is not identified in the list, rejects the request at a radiohardware level rather than at an upper software level. This cansignificantly reduce the time and battery power associated withrejecting data connection requests from unwanted devices. In someembodiments, there can be more than one allowed display device. That is,there can be multiple display devices that are connected to andcommunicating with the analyte sensor system 8 at the same time.

In certain embodiments, the analyte sensor system 8 can also storeinformation identifying one or more display devices that have beenpreviously paired with the transceiver. In some embodiments, suchinformation is stored in the same list or memory where the informationidentifying the single allowed display device is stored. In otherembodiments, such information is stored in a different list or memory.By storing this information, the devices can form an authenticatedcommunication more quickly and efficiently.

FIGS. 8A and 8B represent a flow diagram illustrating an exemplarysystem and method for rejecting a data connection request from a displaydevice not identified in a list containing a single allowed displaydevice according to certain aspects of the present disclosure. In someembodiments, however, there can be multiple allowed display devices inthe list. FIG. 8A shows an analyte sensor system 801, a first displaydevice (DD1) 803 and a second display device (DD2) 805. A vertical arrow805 with the designation “Device Identified in List” on the left side ofFIG. 8 identifies the display device currently stored in the listcontaining a single allowed list. In the illustrated example, DD2 805 isthe display device identified in the list in FIG. 8A. In FIG. 8B, thecontent of the list changes from DD2 805 to none to DD1 803.

For ease of illustration only without any intent to limit the scope ofthe disclosure in any way, the analyte sensor system 801 of FIGS. 8A and8B is described with reference to the analyte sensor system 8 depictedin FIG. 4. Similarly, the first and second display devices 8031, 805 aredescribed with reference to the display device 110, 120, 130, 140depicted in FIG. 4.

Connect to FIG. 4 to explain that DD1 and DD2 have been alreadyauthenticated and paired. At the beginning of a first communicationsession 810, the analyte sensor system 801 begins to transmit a firstseries of advertisement signals 812. At this stage, both DD1 803 and DD2805 have been paired with the analyte sensor system 8 in accordance withparing operations 414 and 416 described above with respect to FIG. 4.However, only DD2 805 is currently on the list containing a singleallowed display device. The advertisement signals 812 can be received byboth DD1 803 and DD2 805, the DD2 805 being the display deviceidentified in the list for containing a single allowed display device.In the illustrated example, the DD1 803 receives an advertisement signalfrom the analyte sensor system 8 and responds first by transmitting afirst data connection request 813. The DD2 805 may have also receivedthe advertisement signal but could not respond to the signal before theDD1 803 did. So, a response signal from the DD2 805 is not received orrecognized by the transceiver 316 of the analyte sensor system 8. Bycomparing the ID of the DD1 803 included in the first data connectionrequest 813 to the identification information stored in the list forcontaining a single allowed display device, a processor (e.g., a linklayer (LL) controller) controlling functions of a radio hardware levelof the transceiver 316 determines the DD1 803 is not the display deviceidentified in the list and rejects the first connection request 813 at aradio hardware level. In certain embodiments, the analyte sensor system8 transmits a signal causing the DD1 803 to stop sending additionalconnection requests. In other embodiments, the DD1 803 stops sendingadditional connection requests if it does not receive a response to thefirst advertisement signal within a predetermined time.

In the illustrated example, after rejecting the first data connectionrequest 813 from the DD1 802, the transceiver 316 of the analyte sensorsystem 801 continues to transmit additional advertisement signals duringthe first wireless communication session 810 as shown in FIG. 8A. Inresponse to one of the additional advertisement signals, the DD2 805transmits a second data connection request 815. The processor determinesthat the DD2 805 is the display device identified in the list forcontaining a single allowed device and grants the request. Uponcompletion of the data connection, the DD2 805 transmits a request fordata 817 (e.g., analyte data) from the analyte sensor system 801 and theanalyte sensor system 801 transmits the requested data 818 to the DD2805. After completion of the data communication process 817, 818, thedata connection between the analyte sensor system 801 and the DD2 805 isterminated/closed and the transceiver 316 of the analyte sensor system801 is deactivated by causing it to enter a sleep mode.

After a period of inactivity, indicated by the inactive timeT_(Inactive) (during which an analyte measurement can be made by theanalyte sensor 312 as described above with respect to FIG. 4), a secondcommunication session 820 begins with the transceiver 316 of the analytesensor system 801 beginning to transmit a second series of advertisementsignals 822. This time, the DD2 805 receives an advertisement signal andresponds first by transmitting a second data connection request 815. Bycomparing the ID of the DD2 805 included in the second data connectionrequest 815 to the identification information stored in the list forcontaining a single allowed display device, the processor of the analytesensor system 810 determines that the DD2 805 is the currently alloweddisplay device and grants the request, e.g., by transmitting a signal826 indicative of the grant. Upon completion of the data connection, theDD2 805 transmits a request for data 827 and the analyte sensor system801 transmits the requested data 828. After completion of the datacommunication process 827, 828, the data connection between the analytesensor system 801 and DD2 805 is terminated/closed and the transceiver316 of the analyte sensor system 801 is deactivated by causing it toenter a sleep/powered-down mode.

If a certain predetermined condition is met, the list for containing asingle allowed display device may be cleared so that another displaydevice can connect to the analyte sensor system 8 without being rejectedat the radio hardware level. This feature solves the problem of tryingto connect with a new display device when the current display device onthe list is lost or not working. FIG. 8B illustrates one exemplaryprocess by which the list can be cleared when no data connection requestis received from the display device identified in the list within apredetermined number (N) of wireless communication sessions 830 ₁-830_(N). As can be seen in FIG. 8B, N sets of advertisement signals 832₁-832 _(N) are transmitted and no data connection request is receivedfrom the DD2 805, the display device identified in the list forcontaining a single allowed display device. When this occurs, theprocessor controlling the radio functions of the transceiver 316 erasesthe information identifying the DD2 805 stored in the list.

In a subsequent communication session 840, the transceiver 316 transmitsa set of advertisement signals 842 and, this time, a third dataconnection request 845 is received from the DD1 803. Note that, at thisstage, the list for containing a single allowed display device is empty.Upon receiving the third data connection request 845, the processorcontrolling the radio functions of the transceiver 316 grants therequest 845 and writes information identifying the DD1 803 in the list.As long as the DD1 803 is identified in the list, subsequent dataconnection requests received from the DD1 803 would be granted withoutbeing rejected at the radio hardware level.

Another predetermined condition that can cause the list to be cleared isreception of a signal from the listed display device (i.e., the displaydevice identified in the list) that indicates that the listed displaydevice to be cleared from the list. This can happen, for example, whenthe user who wants to switch to another display device (e.g., from amobile phone 120 to a custom display device 120 or vice versa)explicitly enters a command on the currently listed display device toclear the listed display device from the list. Another possibility isthat the listed device automatically transmits the clearance signal ifit determines that the device is about to be turned off due to a lowbattery level, for example.

As described above, the analyte sensor system 8 is also configured tostore information identifying one or more display devices that have beenpaired with the transceiver either in the same list or in a differentlist. If such information is not stored in the analyte sensor system 8,meaning that no other display device has been paired with thetransceiver, the transceiver continues to accept data connectionrequests from one or more display devices until at least one displaydevice is paired with the transceiver and information identifying thepaired display device is stored in a list for storing one or morepreviously paired display devices.

FIGS. 9A and 9B represent a flow diagram illustrating an exemplaryprocedure for facilitating a switch between two display devices thatmakes use of two separate lists according certain aspects of the presentdisclosure. A first list is for containing information identifying oneor more allowed display devices and a second list is for containinginformation identifying a single currently active display device, i.e.,a display device that has been selected to receive and display analytevalues from the analyte sensor system. The first list is preferablyimplemented in a memory associated the processor controlling functionsof the transceiver at a radio hardware level described above. The secondlist can be implemented in the same memory comprising the first list orin a different memory.

For ease of illustration only without any intent to limit the scope ofthe disclosure in any way, the analyte sensor system 901 of FIGS. 9A and9B is described with reference to the analyte sensor system 8 depictedin FIG. 4. Similarly, the first and second display devices 903, 905 aredescribed with reference to the display device 110, 120, 130, 140depicted in FIG. 4.

At this stage, both DD1 903 and DD2 905 have been paired with theanalyte sensor system 901 in accordance with paring operations 414 and416 described above with respect to FIG. 4 and are on the listcontaining allowed display devices. However, only DD2 905 is currentlyon the list containing a single active display device. In theillustrated example, it is assumed that the user has decided to selectthe DD1 903 as the new active display device to receive and displayanalyte values from the analyte sensor system 901. At the beginning of afirst communication session 910 shown in FIG. 9A, the transceiver 316 ofthe analyte sensor system 801 begins to transmit a first series ofadvertisement signals 912. The advertisement signals 812 can be receivedby both DD1 903 and DD2 905. As indicated by two vertical arrows in theleft side of the figure, at this stage, both DD1 903 and DD2 905 areidentified in the first list for containing information identifying oneor more allowed display devices and only DD2 905 is identified in thesecond list for containing information identifying a single activedisplay device. The DD1 903, the newly selected active display device,receives an advertisement signal from the analyte sensor system 901 andresponds first by transmitting a data connection request 913 to theanalyte sensor system 901. By comparing the ID of the DD1 903 includedin the first data connection request 913 to the data stored in the firstlist for containing one or more allowed display devices, the processor(e.g., a link layer (LL) controller) controlling functions of thetransceiver 316 at a radio hardware level determines that the DD1 903 isidentified in the first list and grants the data connection request 914by transmitting a signal 914 indicating the grant to the DD1 903.

The DD1 903 then transmits a request 915 for identification of thedisplay device identified in the second list. The analyte sensor system901 responds to the request 915 by transmitting a signal 916 indicatingthat the DD2 905 is identified in the second list. Upon receiving thesignal 916, the DD1 903 transmits a signal 917 indicating that it hasbeen selected as a new active display device. In response, the analytesensor system 901 changes the second list to indicate that the DD1 903is the currently active display device. In some embodiments, the analytesensor system 901 also transmits a signal 918 indicating that the DD1903 is now identified in the second list. From the signal 919, the DD2905 can be notified that the display device 905 is no longer the activedisplay device and can cause the display device 905 to stop respondingto advertisement signals during a next communication session and/or toenter an inactive state. After transmission of the signal 917 (andpossibly also the signal 918), the data connection is terminated and thetransceiver 316 is deactivated, thereby completing the first wirelesscommunication session 910.

After a predetermined period of inactivity indicated by the inactivetime T_(Inactive) (during which one or more analyte measurements fromthe analyte sensor 312 can be taken), a second wireless communicationsession 920 begins with the transceiver 316 of the analyte sensor system901 beginning to transmit a second series of advertisement signals 922.The DD1 903 receives an advertisement signal and responds first bytransmitting a second data connection request 923. Upon receiving thesecond data connection request 923, the analyte sensor system 901determines that the DD1 903 is identified in the first list andtransmits a signal 924 indicating a grant of the second data connectionrequest 923 to the DD1 903. The DD1 903 then transmits a request 925 fordata and the analyte sensor system 901 responds to the request 925 bytransmitting the requested data 926. After the data communication 925,926, the data connection is terminated and the transceiver 316 isdeactivated, thereby completing the second wireless communicationsession 920.

FIG. 9B illustrates what happens when a display device that is not thecurrently active display device sends a data connection request to theanalyte sensor system 901 according to certain aspects of the presentdisclosure. In the illustrated example, in a third wirelesscommunication session 930, the DD2 905 transmits a third data connectionrequest 933 in response to a series of advertisement signals 932transmitted from the analyte sensor system 901. In response to the thirddata connection request 933, the analyte sensor system 901 grants thethird data connection request 933 after determining that the DD2 905 isidentified in the first list and transmits a signal 924 indicating thegrant to the DD2 905. The DD2 905 then transmits a request 936 foridentification of the display device identified in the second list. Theanalyte sensor system 901 responds to the request 936 by transmitting asignal 937 that the DD1 902 is identified in the second list. Uponreceiving the identification information 937, the DD2 905 transmits asignal 938 indicating that the display device 905 is not a newlyselected active display device. In response, the analyte sensor system901 terminates/closes the data connection and in some embodiments thetransceiver 316 may be deactivated (i.e., caused to enter a sleep state)without changing the second list. Because the second list was notchanged during the third communication session 930 and therefore stillidentifies the DD1 903 as the currently active display device, a dataconnection process 943 ad 945 and data communication process 946, 947occur normally during a fourth wireless communication session 940 shownin FIG. 9B.

In the system and method of FIGS. 9A and 9B, only one active displaydevice is allowed to establish a data connection with the analyte sensorsystem 901 and receive sensor information such as analyte data from thesensor system 901. In general, more than one display devices can beallowed to establish data connections with the analyte sensor system901. However, for the ease of illustration, only one active displaydevice is allowed to establish a data connection in the example of FIGS.9A and 9B. In some embodiments, the list containing one or more alloweddisplay devices and/or the list containing one or more active displaydevices can be erased if no connection request(s) are received from thedisplay devices on the list(s) for a predetermined number of wirelesscommunication sessions. In some cases, it is desirable to allow apassive device to receive analyte data and/or other information from theanalyte sensor system without being paired and/or connected to theanalyte sensor system. FIG. 10 is a diagram illustrating a wireless datacommunication system 1000 including an analyte sensor system 1010, anactive display device 1020, and a passive device 1050 according tocertain aspects of the present disclosure. In the illustrated example,the analyte sensor system 1010 is a continuous glucose sensor systemcomprising a sensor electronics module 1012 and a continuous glucosesensor 1014; the active display device 1020 is a mobile phone; and thepassive device 1050 is an insulin pump for administering insulin to theuser. For a variety of reasons, it may be desirable for the insulin pump1050 to receive and track glucose values transmitted from the continuousglucose sensor system 1010. One reason is to provide the insulin pump1050 a capability to suspend insulation administration when the glucosevalue falls below a threshold value. One solution that allows a passivedevice (e.g., the insulin pump 1050) to receive desired data (e.g.,glucose values) without needing to establish an authenticatedcommunication channel with the analyte sensor system (e.g., the glucosesensor system 1010) is to include the desired data in the advertisementsignals transmitted from the analyte sensor system. The data included inthe advertisement signals can be encoded so that only a device that hasthe identification information associated with the analyte sensor system1010 can decode the data. In some embodiments, the active display device1020 extracts and uses the data included in the advertisement signals.In other embodiments, the active display device 1020 does not extractthe data included in the advertisement signals and instead obtains thedata after the display device 1020 establishes a data connection withthe analyte sensor system 1010 in the manner described above withrespect to FIG. 4.

FIG. 11 is a flowchart illustrating an exemplary process 1100 forallowing a passive device to receive desired data from an analyte sensorsystem without being paired or connected to the analyte sensor systemaccording to certain aspects of the present disclosure. The process 1100begins at a start state 1101 and proceeds to operation 1110 where atransceiver of the analyte sensor system 1010 exits a sleep mode andbegins to transmit a series of advertisement signals that include ananalyte value (or other information to be used by the passive device).The process 1100 proceeds to operation 1120 where the passive device1050 receives a first advertisement signal including the analyte value.In certain embodiments, the analyte value included in the advertisementsignals is encoded so that the analyte value can be read or decoded onlyby having identification information associated with the analyte sensorsystem 1010. As an example, the user previously entered a serial numberassociated with the analyte sensor system 1010 into the passive displaydevice. The process 1100 proceeds to operation 1130 where the passivedevice 1050 extracts the analyte value from the first advertisementsignal. In those embodiments where the analyte value included in theadvertisement signals is encoded, the extracting process involvesdecoding the encoded analyte value using a key or code that can begenerated by the use of the identification information associated withthe analyte sensor system 1010. The passive device 1050 can use theextracted analyte value for various purposes. For example, in thoseembodiments where the passive device 1050 is an insulin pump, theextracted glucose value can be displayed on an interface of the device1050, used for calculating an optimal insulin administration rate,and/or to suspend the insulin administration when the glucose valuefalls below a threshold value.

The process 1100 proceeds to operation 1140 where the active displaydevice 1020 receives an advertisement signal from the transceiver of theanalyte sensor system 1010. This advertisement signal can be the same asthe one received by the passive device or a different one. The process1100 proceeds to operation 1150 where the active display device 1020establishes a data connection with the transceiver using one or moredata connection processes, examples of which are described above withrespect to FIGS. 4, 5, 6, 7, 8A, 8B, 9A, 9B. The process 1100 proceedsto operation 1170 where the active display device 1020 requests andreceives an analyte value or other information from the analyte sensorsystem 1010 using one or more data communication processes, example ofwhich are described above with respect to FIGS. 4, 5, 6, 7, 8A, 8B, 9A,9B. The process 1100 proceeds to operation 1180 where the analyte sensorsystem 1010 terminates the data connection with the active displaydevice 1020 and causes the transceiver of the analyte sensor system 1010to enter a sleep mode. The process 1100 repeats by looping back to theoperation 1110.

The various implementations of the subject matter described herein maybe realized in digital electronic circuitry, integrated circuitry,specially designed ASICs (application specific integrated circuits),computer hardware, firmware, software, and/or combinations thereof. Thecircuitry may be affixed to a printed circuit board (PCB), or the like,and may take a variety of forms, as noted. These various implementationsmay include implementation in one or more non-transitory computerprograms that are executable and/or interpretable on a programmablesystem including at least one programmable processor, which may bespecial or general purpose, coupled to receive data and instructionsfrom, and to transmit data and instructions to, a storage system, atleast one input device, and at least one output device.

These computer programs (also known as programs, software, softwareapplications, or code) include machine instructions for a programmableprocessor, and may be implemented in a high-level procedural and/orobject-oriented programming language, and/or in assembly/machinelanguage. As used herein, the term “machine-readable medium” refers toany non-transitory computer program product, apparatus and/or device(e.g., magnetic discs, optical disks, memory, Programmable Logic Devices(PLDs)) used to provide machine instructions and/or data to aprogrammable processor, including a machine-readable medium thatreceives machine instructions.

While the disclosure has been illustrated and described in detail in thedrawings and foregoing description, such illustration and descriptionare to be considered illustrative or exemplary and not restrictive. Thedisclosure is not limited to the disclosed embodiments. Variations tothe disclosed embodiments can be understood and effected by thoseskilled in the art in practicing the claimed disclosure, from a study ofthe drawings, the disclosure and the appended claims.

All references cited herein are incorporated herein by reference intheir entirety. To the extent publications and patents or patentapplications incorporated by reference contradict the disclosurecontained in the specification, the specification is intended tosupersede and/or take precedence over any such contradictory material.

Unless otherwise defined, all terms (including technical and scientificterms) are to be given their ordinary and customary meaning to a personof ordinary skill in the art, and are not to be limited to a special orcustomized meaning unless expressly so defined herein. It should benoted that the use of particular terminology when describing certainfeatures or aspects of the disclosure should not be taken to imply thatthe terminology is being re-defined herein to be restricted to includeany specific characteristics of the features or aspects of thedisclosure with which that terminology is associated. Terms and phrasesused in this application, and variations thereof, especially in theappended claims, unless otherwise expressly stated, should be construedas open ended as opposed to limiting. As examples of the foregoing, theterm ‘including’ should be read to mean ‘including, without limitation,’‘including but not limited to,’ or the like; the term ‘comprising’ asused herein is synonymous with ‘including,’ ‘containing,’ or‘characterized by,’ and is inclusive or open-ended and does not excludeadditional, unrecited elements or method steps; the term ‘having’ shouldbe interpreted as ‘having at least;’ the term ‘includes’ should beinterpreted as ‘includes but is not limited to;’ the term ‘example’ isused to provide exemplary instances of the item in discussion, not anexhaustive or limiting list thereof; adjectives such as ‘known’,‘normal’, ‘standard’, and terms of similar meaning should not beconstrued as limiting the item described to a given time period or to anitem available as of a given time, but instead should be read toencompass known, normal, or standard technologies that may be availableor known now or at any time in the future; and use of terms like‘preferably,’ ‘preferred,’ ‘desired,’ or ‘desirable,’ and words ofsimilar meaning should not be understood as implying that certainfeatures are critical, essential, or even important to the structure orfunction of the invention, but instead as merely intended to highlightalternative or additional features that may or may not be utilized in aparticular embodiment of the invention. Likewise, a group of itemslinked with the conjunction ‘and’ should not be read as requiring thateach and every one of those items be present in the grouping, but rathershould be read as ‘and/or’ unless expressly stated otherwise. Similarly,a group of items linked with the conjunction ‘or’ should not be read asrequiring mutual exclusivity among that group, but rather should be readas ‘and/or’ unless expressly stated otherwise.

Where a range of values is provided, it is understood that the upper andlower limit, and each intervening value between the upper and lowerlimit of the range is encompassed within the embodiments.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity. The indefinite article “a” or “an” does not exclude aplurality. A single processor or other unit may fulfill the functions ofseveral items recited in the claims. The mere fact that certain measuresare recited in mutually different dependent claims does not indicatethat a combination of these measures cannot be used to advantage. Anyreference signs in the claims should not be construed as limiting thescope.

It will be further understood by those within the art that if a specificnumber of an introduced claim recitation is intended, such an intentwill be explicitly recited in the claim, and in the absence of suchrecitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

All numbers expressing quantities of ingredients, reaction conditions,and so forth used in the specification are to be understood as beingmodified in all instances by the term ‘about.’ Accordingly, unlessindicated to the contrary, the numerical parameters set forth herein areapproximations that may vary depending upon the desired propertiessought to be obtained. At the very least, and not as an attempt to limitthe application of the doctrine of equivalents to the scope of anyclaims in any application claiming priority to the present application,each numerical parameter should be construed in light of the number ofsignificant digits and ordinary rounding approaches.

Furthermore, although the foregoing has been described in some detail byway of illustrations and examples for purposes of clarity andunderstanding, it is apparent to those skilled in the art that certainchanges and modifications may be practiced. Therefore, the descriptionand examples should not be construed as limiting the scope of theinvention to the specific embodiments and examples described herein, butrather to also cover all modification and alternatives coming with thetrue scope and spirit of the invention.

1-7. (canceled)
 8. An analyte sensor system configured for a wirelessdata communication with a plurality of display devices capable ofdisplaying analyte values from the analyte sensor module, the analytesensor system comprising: an analyte sensor; a transceiver configured totransmit and receive wireless signals; and a processor operativelycoupled to the analyte sensor, and the transceiver and configured to:cause the transceiver to transmit a first series of advertisementsignals, receive a first data connection request from a first displaydevice, determine that the first display device is identified in a firstlist containing one or more allowed display devices, establish a firstdata connection with the first display device, read from a second listfirst data identifying a different display device as a currently activedisplay device, transmit the first data to the first display device,receive a request to write to the second list second data identifyingthe first display device as a currently active display device, write thesecond data to the second list, and terminate the first data connectionwith the first display device.
 9. The analyte sensor system of claim 8,wherein the analyte sensor is a continuous glucose sensor.
 10. Theanalyte sensor system of 8, wherein at least one of the first displaydevice and the different display device is a custom analyte monitoringdevice and the other of the first display device and the differentdisplay device is a mobile device.
 11. The analyte sensor system of 9,wherein at least one of the first display device and the differentdisplay device is a custom analyte monitoring device and the other ofthe first display device and the different display device is a mobiledevice.
 12. The analyte sensor system of claim 11, wherein the mobiledevice is a mobile phone.
 13. The analyte sensor system of claim 8,wherein the processor is configured to reject a data connection requestfrom a display device not identified in the first list at a radiohardware level.
 14. The analyte sensor system of claim 9, wherein theprocessor is configured to reject a data connection request from adisplay device not identified in the first list at a radio hardwarelevel.
 15. The analyte sensor system of claim 14, wherein the processorcomprises a link layer (LL) controller.
 16. The analyte sensor system ofclaim 15, wherein the first list is a white list maintained in the LLcontroller.
 17. The analyte sensor system of claim 8, wherein theprocessor is further configured to: cause the transceiver to transmit asecond series of advertisement signals, receive a second data connectionrequest from the first display device, cause the transceiver toestablish a second data connection with the first display device,determine that the first display device is identified in the secondlist, cause the transceiver to transmit an analyte value to the firstdisplay device, and cause the transceiver to terminate the second dataconnection with the first display device.
 18. The analyte sensor systemof claim 9, wherein the processor is further configured to: cause thetransceiver to transmit a second series of advertisement signals,receive a second data connection request from the first display device,cause the transceiver to establish a second data connection with thefirst display device, determine that the first display device isidentified in the second list, cause the transceiver to transmit ananalyte value to the first display device, and cause the transceiver toterminate the second data connection with the first display device. 19.The analyte sensor system of claim 18, wherein the processor is furtherconfigured to: cause the transceiver to enter a sleep mode, and causethe transceiver to exit the sleep mode after a predetermined time. 20.The analyte sensor system of claim 19, wherein the predetermined time isbetween about 200 and 300 seconds.
 21. The analyte sensor system ofclaim 19, wherein the processor is further configured to take ameasurement of an output of the analyte sensor while the transceiver isin the sleep mode.
 22. The analyte sensor system of claim 19, whereinthe processor is further configured to: cause the transceiver totransmit a third series of advertisement signals after exiting, receivea third data connection request from a second display device, cause thetransceiver to establish a third data connection with the second displaydevice if it is determined that the second display device is identifiedin the first list, cause the transceiver to transmit a third signal tothe second display indicating that a different display device isidentified in the second list, receive a fourth signal from the seconddisplay device, the fourth signal indicating that the third displaydevice is not a newly selected active display device, and cause thetransceiver to terminate the third data connection with the seconddisplay device without changing the second list.